CITATION: Taylor v. Canada (Attorney General), 2020 ONSC 1192  
COURT FILE NO.: CV-181819  
DATE: 20200227  
) John Legge, Steve Pengelly, David Steeves,  
) and Brian Moher for the Plaintiff  
and –  
Sean Gaudet, James Soldatich, Andrew Law,  
James Gorham, Roger Flaim, for the  
James Newland, Neil Wilson for the Ontario  
Health Insurance Plan  
) HEARD: April 1-3, 5, 8-12, 23-26, 29, 30;  
) May 1-3, 6-12, 15, 23-26. 29-31; June 3-5,  
) 10-13, 17-21; September 16-20, 23; October  
) 7-9, 2019  
Government regulates many areas of our lives. This regulatory activity is part of what  
organizes our society, confirms its values and, in some circumstances, gives direction to what we  
can, should or might do. In a culture which values the individual and encourages other  
participants (say universities, research entities and corporations) to find solutions to common  
concerns, locating the balance between public and private responsibility when things go wrong is  
a complicated problem. This case enters into this difficult question but in what turns out to be a  
limited way.  
The area being regulated is a form of medical treatment, not the activity of the  
professionals involved (doctors and nurses), or the use of drugs but instead so called “devices”  
that may improve the circumstances of those in need of relief. This includes, for example, any  
apparatus that may be used to augment the structure of the body and improve its function. In this  
Page: 2  
case, Vitek Inc., a corporation located in Houston, Texas was promoting and selling a proprietary  
product (“Proplast”) for a variety of uses associated with an array of physical issues of concern  
to many people. Of particular relevance was its use in implants designed to replace the meniscus  
in the jaw to alleviate discomfort and improve performance. This occurred at a time of growing  
government interest in the entry of these devices into the market and the perceived need for  
increased regulation to meet their arrival. Devices using Proplast were implanted into some  
Canadian citizens. Today, it is generally accepted that Proplast is frangible (fragile, brittle),  
breaks down and that the resulting particles may distribute themselves causing much suffering  
and pain such that the use of the jaw may become restricted, in some cases ineffectual. The  
Plaintiff says that the defective nature of the product was well-known and understood long  
before these implants were put in place. It is said that the fault for the harm that resulted lies, in  
part, with the government for its failure to properly regulate and control the entry of Proplast  
products into the market and its failure to respond appropriately after the difficulties of the  
recipients of these implants became apparent.  
This is a class action. It has a history, not a happy one. The implants which mark the  
beginning took place at some point between 1983 and 1990. This action was commenced in  
1999. It has taken 20 years to bring it to trial. By my count, from the trial record, with the  
delivery of these reasons, no fewer than 23 judicial officers (Masters, Superior Court and Court  
of Appeal judges) will have touched this proceeding.  
The initial representative plaintiff was Judith Logan. In 2002 an effort was made to add,  
as a plaintiff, Wendy Bulloch-MacIntosh. She had commenced an individual action. The stated  
purpose of the motion was to add to the certification record information elicited from  
representatives of the Crown during the discovery in that separate proceeding. There was a  
threshold issue. Could the individual action be stayed but left in place if Wendy Bulloch-  
MacIntosh became a representative plaintiff in the class action? Initially, the judge considering  
the matter indicated a willingness to hear further submissions. In the end, the plaintiff withdrew  
the request.1 In 2003, Judith Logan was replaced by Kevan Drady and the present representative  
plaintiff, Kathryn Anne Taylor.2 Kevan Drady withdrew in 2006 to commence a separate class  
action alleging negligence over the regulation, by Health and Welfare Canada, of a different  
implant, that one using “silastic” (a combination of silicone and plastic), not Proplast. That  
action was struck out by the Court of Appeal in 2008 for failing to disclose a reasonable cause of  
1 Trial Record at T. 11 and T. 12 (Endorsements of Mr. Justice Winkler respectively dated February 13, 2002 and  
May 15, 2002.)  
2 Ibid at T. 13 and T. 14 (Respectively the Reasons and Order of Mr. Justice Winkler.)  
3 Drady v. Canada, 2008 ONCA 659 (CanLII), 300 DLR (4th) 443, 270 OAC 1, 68 CPC (6th) 306, [2008] OJ No  
3772 (QL), 169 ACWS (3d) 683  
Page: 3  
The first substantive issue that comes to mind is whether, given the time lapse, the action  
was commenced outside the applicable limitation periods. At the time, there were two limitations  
that could have impacted this case. The first, 6 years as found in the Limitations Act4, and the  
second the Crown Liability and Proceedings Act5 which, in turn, adopted whatever provisions  
applied in the province where the cause of action arose being, in this case, the Proceedings  
Against the Crown Act of Ontario. That Act required that at least 60 days before the  
commencement of an action against the Crown a notice of the claim be served on the Crown.  
The issue of applicable limitations arose as part of a motion heard considering the substitution of  
the original representative plaintiff. The question was whether the substitution could not take  
place because, in the absence of certification, the putative class action remained an individual  
action. This would mean that the “tolling” of the applicable limitation period through the Class  
Proceedings Act, 19927 had not become effective. The motion judge did not accept this  
submission. In any case, as he saw it, there was no need to start a new action. “The most  
appropriate approach to deal with the motion to substitute in the present circumstances is by way  
of amendment, pursuant to the jurisdiction granted to the court under ss. 12 and 14 of the CPA  
[Class Proceedings Act] rather than for the new representative plaintiffs to commence a fresh  
proceeding.”8 Apparently, the issue of whether the action as commenced in the name of Judith  
Logan was out of time did not come up. However, it did in the appeal that followed:  
In any event the motion judge did not deal with that argument and I can only  
assume it was because the argument was not put in that way. In any event,  
however it is clear from the disposition made by the motion judge that because the  
claim is that the breaches by the appellant are continuing, the action was not, on  
its face, barred by the passing of the limitation period.9  
of whether this action was out of time has not been raised since. It was not raised at this trial.  
The appeal was dismissed. The substitution was allowed.10 So far as I am aware the issue  
The certification of this action as a class proceeding was not finalized until July 6, 2012  
following a determination made by a five-judge panel of the Court of Appeal. What did it take to  
get to that point? During May, 2000, the plaintiff (still Judith Logan) brought a motion to certify  
the action as a class proceeding.11 On October 3, 2000, a motion to strike certain materials  
included in the Motion Record filed, by the Plaintiff, in support of the motion to certify the  
action was heard. Of the six contested items, two were withdrawn, three were struck and for one,  
the issue declared moot.12  
4 R.S.O. 1990, c. L.15  
5 R.S.C., c. C-50  
6 R.S.O. 1990, c. P. 27  
7 S.O. 1992, c. 6, s. 28  
8 Trial Record at T. 13 (Endorsement of Mr. Justice Winkler at paras. 14-25 (The sentence quoted is at para. 25))  
9 Logan v Canada (Minister of Health) 2004 Canlli 184 (ON CA), 71 OR (3d) 451, 188 OAC 294 at para. 15  
10 Ibid and Trial Record at T. 19 (Respectively the Decision and Order of the Court of Appeal both of June 29, 2004)  
11 Trial Record at T. 7 (Endorsement of Master MacLeod dated July 25, 2001) at para. 12  
12 Ibid at T. 4 and T. 5 (Respectively, the handwritten endorsement and Order of Mr. Justice Winkler dated October  
3, 2000.)  
Page: 4  
On July 25, 2001, Master MacLeod dealt with a motion, generally, concerning the refusal  
to answer questions during a cross-examination conducted in preparation for a motion to amend  
the pleadings. What is apparent is that the difficulties that have marked the overall conduct of  
this action had already appeared:  
A form of procedural gridlock has arisen over this issue notwithstanding  
admonitions by the case management judge.13  
An appearance was necessary to settle the order. The difficulties that had presented  
themselves continued. The Master was required to underscore that the order he had made  
required the deponents to the affidavits to reattend to answer the questions asked, as well as  
reasonable follow-up questions. As the Master noted, while the issue of a re-attendance is  
discretionary, the permission to permit a subsequent examination was, and remains, the “usual  
order”. The Master felt the need to go on:  
I find it an extraordinary submission that the credibility of these witnesses will  
remain an issue on the motion.14  
[10] It seems the Master also had to consider and deal with an allegation of some sort of  
improper conduct of counsel for the Plaintiff:  
I do not view the affidavits provided by Mr. Legge as an improper attempt to  
unilaterally determine the mode of examination but rather as an attempt to provide  
timely answers in a cost effective manner.15  
[11] The Master noted the Crown’s response to whatever problem it saw:  
Nevertheless, the Crown insists on proceeding orally and there has been no  
persuasive argument why this should not be allowed.16  
[12] This all has to do with a refusals motion. One has to wonder why all this obfuscation was  
thought to be necessary.  
[13] The certification motion was considered in reasons delivered on September 5, 2007. The  
action was certified:  
The allegations are consistent with an interpretation that Health Canada's failure  
to take steps to enforce the regulations and its directions to the distributor of the  
devices - despite its knowledge that they were being breached - facilitated the  
13 Ibid at T.7 (Endorsement of Master MacLeod dated July 25, 2001 at para. 12.)  
14 Ibid at T.10 (Endorsement of Master MacLeod dated October 9, 2001, p. 2.)  
15 Ibid at T. 10, p. 2  
16 Ibid at T. 10, p. 2  
Page: 5  
continued sale of the devices and thereby created a risk to the health of the  
intended recipients. Health Canada’s alleged failure to enforce the regulations  
when it was aware that sales of the implants were continuing after it had given  
notice of breaches on a number of occasions over a period of six or seven years,  
could only have encouraged the importer/distributor to believe that it could ignore  
its statutory obligations, and Health Canada’s warnings, with complete impunity.  
In these circumstances, I believe it would be open to a court to find that Health  
Canada’s course of conduct – including the dissemination of the misinformation  
in its database - increased the risk to the health of the plaintiff and other potential  
recipients of the implants and gave rise to a relationship of proximity with them.17  
[14] The Court pointed out the limits of this determination:  
It is possible that the plaintiff will not be able to prove the allegations of fact in  
the statement of claim - or that a different complexion may be placed on them  
when all the evidence on each side is before the court at trial. These are not  
matters I am concerned with on this motion.  
[15] But went on to confirm the then pertinent conclusion:  
On the basis of the pleading alone, I do not consider it to be plain and obvious that  
Ms. Taylor has no chance of success in establishing that a relationship of  
proximity as required to establish a private law duty of care existed in  
connection with operational acts of Health Canada. I believe this conclusion is  
consistent with the cases I have cited, and others18  
[16] A motion was brought to the Divisional Court seeking leave to appeal the order certifying  
the class action. Leave was refused.19  
[17] This was not the end of the Court considering the question of certification of the  
proceeding as a class action.  
[18] A year after the certification motion, the Court of Appeal released its decision in Drady v.  
Canada.20 It too considered implants to the jaw. In that case, in this Court, the year before, the  
same judge, as on the certification motion, had struck the Statement of Claim. Proximity was not  
apparent because the plaintiff was unable to identify the particular implant he had received as  
being manufactured by Vitek Inc.:  
17 Taylor v. Canada (Health), 2007 CanLII 36645 (ON SC), 285 DLR (4th) 296, 49 CPC (6th) 36, [2007] OJ No  
3312 (QL), 160 ACWS (3d) 385 at para. 39  
18 Ibid at para. 40. (The other citations referred to at the end of the quotation are: Sauer v. Canada (Attorney  
General),2007 ONCA 454 (CanLII), [2007] O.J. No. 2443 (C.A.); Swanson Estate v. The Crown (1991), 1991  
CanLII 8226 (FCA), 80 D.L.R. (4th) 741 (F.C.A.); and Williams v. Canada (Minister of Health) (2005), 2005 CanLII  
29502 (ON SC), 76 O.R. (3d) 763 (S.C.J.))  
19 Taylor v. Canada (Attorney General), 2007 CanLII 55708 (ON SCDC), 289 DLR (4th) 567, 233 OAC 111, —  
[2007] OJ No 4947 (QL), 163 ACWS (3d) 368  
20 Supra (fn. 3)  
Page: 6  
In these circumstances independently of any other considerations - the facts  
alleged with respect to the Crown's operational negligence with respect to the  
Vitek Proplast implants are, in my judgment, insufficient to give rise to  
relationship of proximity between it and Mr Drady. Under the FDA and the  
regulations, the Crown does not regulate devices generically or by categories. Its  
powers and responsibilities are confined to dealing with particular devices sold, or  
to be sold, in Canada on a case by case basis. The Crown's alleged negligence in  
respect of the defaults of the Vitek Proplast implant vendor cannot create  
proximity with Mr Drady if it is not alleged that he received such a device.  
Independently of any other consideration, a causal relationship between the  
plaintiff, the device and its vendor is an essential link in the creation of a  
relationship of proximity. …21  
[19] The device implanted in Kevan Drady did not use or contain Proplast. It relied on silastic.  
The Court of Appeal in Drady considered the Superior Court decisions in both that case and this  
one. It confirmed the decision that, in Drady, there was no proximity between the Crown and the  
plaintiff. There being no proximity, it was plain and obvious that the action could not succeed.  
[20] At about the same time as the decision of the Court of Appeal in Drady v. Canada it also  
released its reasons in Attis v. Canada22 which considered the same issues, albeit in relation to  
breast implants rather than jaw implants. The legislative scheme did not demonstrate any  
intention to impose a private law duty of care23 and there was no direct communication or  
interaction between the government and the plaintiff in relation to the operation or  
implementation of a policy such that a duty of care could arise. There was no allegation of any  
representations by Health and Welfare Canada that were capable of supporting a relationship of  
[21] Both Drady and Attis made reference to Sauer v. Canada (Attorney General).25 It runs  
counter to their determination concerning the absence of proximity. In Sauer, a farmer  
commenced a class action as a result of a cow, in Alberta, contracting “BSE” (colloquially “Mad  
Cow Disease). Some countries closed their borders to Canadian beef. The law suit was for  
negligent regulation of the cattle industry and claimed for the financial losses suffered as a result.  
In certifying the action, the judge considering the motion held that a duty of care had been  
disclosed in the pleadings. The Court of Appeal made this observation even though the judge had  
not directly addressed the question.26 The motion judge had moved directly to the issue of  
21 Drady v. Canada, 2007 CanLII 27970 (ON SC), [2007] CarswellOnt 4631, [2007] OJ No 2812 (QL), 159  
ACWS (3d) 177 at paras. 23 and 24  
22 2008 ONCA 660 (CanLII), 93 OR (3d) 35, 300 DLR (4th) 415, 254 OAC 91, 59 CPC (6th) 195, [2008] OJ No  
3766 (QL) , 169 ACWS (3d) 684  
23 Attis v. Canada (Health), supra (fn. 22) at para. 62  
24 Ibid at para. 66 and 68  
25 Sauer v. Canada (Attorney General), 2007 ONCA 454 (CanLII), 225 OAC 143, 31 BLR (4th) 20, 49 CCLT (3d)  
161, [2007] OJ No 2443 (QL), 159 ACWS (3d) 306  
26 Taylor v Canada (Health), 2010 ONSC 4799 (CanLII), 81 CCLT (3d) 106, [2010] OJ No 5936 (QL) at para. 30  
Page: 7  
whether there was a policy rationale for overriding the finding of proximity and the resulting  
duty of care as required by the second stage of the test in Anns v. Merton London Borough  
Council.27 In Sauer v Canada (Attorney General) the Court of Appeal upheld the certification. It  
dealt with the issue of proximity in a single paragraph:  
On the other hand, Sauer argues that he has pleaded the facts required to show  
sufficient proximity between Canada and commercial cattle farmers to raise  
a prima facie duty of care. In particular, he points to the many public  
representations by Canada that it regulates the content of cattle feed to protect  
commercial cattle farmers among others. He says this shows that Canada was  
acting with their interests in mind rather than the broad public interest. Sauer says  
that Canada’s public assumption of a duty to Canadian cattle farmers to ensure the  
safety of cattle feed yields the conclusion that it is not plain and obvious that his  
claim of a prima facie duty of care will not succeed. I agree.28  
[22] Drady and Attis having been decided and based on what they determined, the Crown  
moved, in this action, to strike the Statement of Claim and decertify the class action. The Court  
determined that the pleading failed to disclose a reasonable cause of action but granted the  
plaintiff leave to amend the Statement of Claim. The Court denied the motion to decertify the  
class action.29  
[23] In coming to its decision, the Court took account of how each of Drady and Attis dealt  
with Sauer:  
The treatment of Sauer in these cases is typified by the following comments  
in Attis and Drady:  
[In Sauer] this court found a sufficient pleading of proximity at  
para. 62 on the basis of the many express "public representations  
by Canada that it regulated cattle feed to protect commercial cattle  
farmers among others" (emphasis added). Accordingly, the  
result in Sauer depended on the allegation of specific  
representations by the Government that it was acting in the  
basis, Sauer is  
distinguishable because the appellants in this case do not plead any  
specific representations by Health Canada that it was acting to  
protect the particular interests of the consumers of breast implants.  
(Attis at para 49)  
[1977] UKHL 4, [1978] AC 726 (The test established in Anns v. Merton London Borough Council, though later  
rejected in England, is still relied on in Canada. It is a broad test for determining the existence of a duty of care. The  
test has two stages. It requires first a sufficient relationship of proximity based upon foreseeability; and secondly  
considerations of reasons (policy) why there should not be a duty of care.)  
28 Sauer v. Canada (Attorney General), supra (fn. 25) at para. 62  
29 Taylor v Canada (Health), supra (fn. 26) at paras. 26, 49, 54 and 76  
Page: 8  
Proximity was also adequately pleaded in Sauer on the basis of the many express  
public representations by the government that it was acting for the explicit  
purpose of protecting the commercial cattle farmers. These representations  
supported the plaintiffs allegation that the government assumed a private law  
duty to act on behalf of the farmers. (Drady at para 42)30  
[24] And concluded:  
The significance attributed to the representations in Sauer would appear to have  
considerable precedential importance for counsel and motions judges when  
considering the kind of representations by the Crown that could give rise to a  
sufficiently close relationship with the plaintiff.31  
[25] In the end it was not plain and obvious that the proximity necessary to demonstrate a  
private duty of care could not be met:  
In these circumstances, I believe I should accept the amended pleading on the  
ground that when it is read generously - it is not plain and obvious that a finding  
of proximity could not be made at trial if the factual allegations pleaded are  
proven. At the very least, in view of the need for clarification of the requirements  
for an effective public assumption of a private law duty of care, I consider  
that this is a case in which it should be held that the particular issue on which  
proximity turns is not fully settled in the jurisprudence within the meaning of the  
decisions cited in paragraph 47 above. In such cases it has been held that the issue  
in dispute is best left to be dealt with at trial on the basis of a full evidentiary  
[26] Instead of proceeding to the Divisional Court and recognizing the confusion the mix of  
cases then extant had caused, the Crown determined to move directly to the Court of Appeal. A  
motion was brought for leave to have a special case determined. The judge opened his reasons  
observing that “[t]his action has had a tortured history”.33 It was 10 years after the action had  
been commenced. There had been no progress. The motion was granted, in part out of concern  
for the delay:  
The parties have indicated to me that this litigation has already become a  
procedural marathon. If the case was to follow through the normal course in the  
Divisional Court with leave to appeal and appeal in the Divisional Court,  
followed by the inevitable application for leave to appeal to this court and the  
appeal in this court, then several more months -- if not a couple of years -- will  
30 Taylor v Canada (Health), supra (fn. 26) at para. 35  
31 Taylor v Canada (Health), supra (fn. 26) at para. 37  
32 Taylor v Canada (Health), supra (fn. 26) at para. 73  
33 Taylor v. Canada (Attorney General) 2011 ONCA 181, 104 OR (3d) 481, 277 OAC 126, [2011] OJ No 949 (QL).  
(A Notice seeking leave to appeal to the Divisional Court, dated September 15, 2010 was filed but no action taken  
pending the outcome of the motions seeking a special case (at para. 19).)  
Page: 9  
have passed. This action was commenced in December 1999 and pleadings have  
not yet closed. So much for access to justice!  
It is time to get this case moving ahead…34  
[27] It is this order that placed the matter before the panel of five judges of the Court of  
Appeal. In its decision the Court of Appeal picked up on the general understanding outlined in  
Attis to the effect that the proximity necessary to found a duty of care can arise from the  
legislation or through direct interaction between the regulator and the individuals impacted:  
The approach taken to the claims in Drady and Attis is consistent with that  
described above. In both cases, this court looked first at the relevant legislative  
scheme and found that it imposed no private law duty of care: see Attis, at  
paras. 53-62; Drady, at paras. 37-39. The court then turned to the pleadings in  
each case to determine whether the interactions between the regulator and the  
plaintiff set forth in the pleadings created a relationship of proximity such as to  
justify a finding of a prima facie duty of care.35  
[28] The Court rejected the finding, apparent in the determination in Sauer, that the “many  
public representations” made by the regulator as to its intention to protect farmers was sufficient  
to support a finding of the proximity required as the basis for the existence of a duty of care:  
In my view, a finding of proximity based entirely on a regulator's public  
acknowledgement of its public duties to those affected by its actions, coupled  
with reliance by those affected on the regulator's public statements, is inconsistent  
with the Supreme Court's rejection in Imperial Tobacco of the claim that Health  
Canada owed a private law duty of care to consumers of low-tar cigarettes  
because it had made public representations as to the relative safety of those  
[29] The Court concluded:  
This is not the time or place to pass upon the ultimate sufficiency of the  
pleadings in Sauer. I am satisfied, however, that the detailed analyses of  
proximity in Attis and Drady, particularly in the light of the subsequent judgment  
in Imperial Tobacco, are more in line with the prevailing jurisprudence. The  
single conclusory observation in Sauer, standing alone, is not consistent with that  
34 Ibid at paras. 27-28  
35 Taylor v. Canada (Attorney General), 2012 ONCA 479 (CanLII), 111 OR (3d) 161, 352 DLR (4th) 690, 293  
OAC 312, 95 CCLT (3d) 88 at paras. 92  
36 Ibid at para 95  
37 Ibid at para. 97  
Page: 10  
[30] However, the Court of Appeal was not prepared to foreclose the possibility of the  
required proximity being available to the Plaintiff. The inquiry is broader than looking for  
immediate and direct interaction between the regulator and the prospective plaintiff:  
Where the legislation is not determinative one way or the other, the courts explore  
the specific circumstances of the interactions between the regulator and the  
plaintiff in the context of the legislative scheme to decide whether a sufficiently  
"close and direct" relationship exists to justify the imposition of a prima facie  
duty of care38  
[31] The Court addressed the substance of that inquiry:  
Findings of proximity based on the interactions between the regulator and the  
plaintiff are necessarily fact-specific. The jurisprudence does, however, suggest  
there are two important factual features in those cases where the court has found a  
prima facie duty of care.39  
[32] And explained the two factual features it found important:  
First, the facts demonstrate a relationship and connection between the regulator  
and the individual that is distinct from and more direct than the relationship  
between the regulator and that part of the public affected by the regulator's  
The second feature of those cases in which the courts have found that the  
interactions between the plaintiff and the regulator created a prima facie duty of  
care arises out of the nature of the duty actually imposed by the legislative  
scheme. While the statutory duties are found to be public duties and not,  
therefore, themselves the basis for any private law duty of care, those public  
duties have been found to be consistent with the existence of a private law duty of  
care owed to an individual plaintiff.41  
[33] On this basis the Court concluded:  
38 Ibid at para. 79 referring to R. v. Imperial Tobacco Canada Ltd., [2011] 3 S.C.R. 45, [2011] S.C.J. No. 42, 2011  
SCC 42 (CanLII), at para. 50; Hill v. Hamilton-Wentworth Regional Police Services Board, [2007] 3 S.C.R.  
129, [2007] S.C.J. No. 41, 2007 SCC 41 (CanLII), 285 D.L.R. (4th) 620, at paras. 26-45; Fullowka v. Pinkerton's of  
Canada Ltd., [2010] 1 S.C.R. 132, [2010] S.C.J. No. 5, 2010 SCC 5 (CanLII), at paras. 37-55; Heaslip Estate v.  
Mansfield Ski Club Inc. (2009), 96 O.R. (3d) 401, [2009] O.J. No. 3185, 2009 ONCA 594 (CanLII), 310 D.L.R.  
(4th) 506, 67 C.C.L.T. (3d) 1, 252 O.A.C. 1, 179 A.C.W.S. (3d) 1224 at paras. 15-31.  
39 Ibid at para. 80  
40 Ibid at para. 80  
41Ibid at para. 88  
Page: 11  
The jurisprudence permits no definitive answer for the first question. As counsel  
for AG Canada put it in his factum, "[t]he requirements for proximity are diverse  
and depend on the facts of each particular case".42  
[34] The Court of Appeal did not stop there:  
there is no allegation of any direct contact between the plaintiff [Kathryn  
Taylor] and Health Canada43  
[35] However, the possibility of proximity remained:  
In my view, it is arguable that the misrepresentations, combined with the failure  
to correct that misrepresentation in the face of knowledge of the serious and  
ongoing risk posed to a clearly definable and relatively small group of consumers,  
could be viewed as akin to the regulator's failure in Fullowka to act in the face of  
the known and ongoing dangers posed to the small and well-defined group of  
miners who worked in the specific mine which the regulator knew to be unsafe.44  
[36] With this, the action was certified and proceeded as a class action.  
[37] Why review this history now? It is unacceptable that it has taken as long as it has for this  
action to proceed to trial. The case is premised on the idea that there is a group of people who  
have been harmed by the alleged neglect of the government. They have been waiting for twenty  
years, their suffering continuing, presumably with the hope, maybe even the expectation, of  
some assistance. No one should be content with the time this has taken. Those involved have to  
ask why they allowed this to happen. Moreover, what the reasons of the Court of Appeal  
demonstrate is that the foundational question to be answered: Did the government owe the  
members of the class a private duty of care, is a limited one. No duty of care is imposed by the  
legislation. Nor, in this situation, is there proximity as a result of direct and immediate  
interaction. What is left is narrow. Is there some identifiable group to which, as a result of some  
action by the government, proximity exists and a duty of care attaches?  
[38] This is not the only limitation imposed through the history of this unfortunate litigation.  
[39] It should go without saying that there are other parties who would have been involved in  
the importing, marketing, selling, purchasing, implanting and observing the results of any  
surgery associated with the placing of Vitek Proplast devices. These would include the  
manufacturer, the distributor, the hospital and various doctors and other professionals. Not  
surprisingly, given that the only defendant in this action is the Crown, it issued Third Party  
Claims. The Trial Record includes an order, dated September 14, 2006, allowing the Crown, on  
consent, to deliver its Amended, Amended, Amended, Amended Third Party Claim.45 There is  
42 Ibid at para. 92  
43 Ibid at para. 107  
44 Ibid at para. 111  
45 Trial Record at T. 23  
Page: 12  
no earlier form of the Third Party Claim in the Trial Record. Clearly, it had been subject to a  
series of changes. There is another order, this one issued on September 25, 2005, as I read it, in  
furtherance of the amendment allowed 10 days earlier. It allowed for the discontinuance of the  
Third Party action against those that, with the amendments that had been ordered in place, were  
no longer the subject of any allegations in the Third Party Claim.46  
[40] The motion that determined that, in Drady, the Statement of Claim disclosed no  
reasonable cause of action was joined by a motion to strike the Third Party Claims in both Drady  
and this case. The question that arose concerned what the Plaintiff was claiming and, in  
particular, did it leave open the prospect that the Crown, if found liable, could have a claim to  
contribution and indemnity as allowed for by the Negligence Act.47 At the outset, counsel for the  
Plaintiff was insistent that the Plaintiff’s claim perceived that the Crown was liable for all of the  
damage she had suffered. Counsel for the moving parties (the Third Parties) relied on “a few  
references to the Crown’s several liability that appeared in the Plaintiff’s pleadings”.48 The Court  
determined that “several” liability did not foreclose the possibility of contribution from others:  
I do not believe there is any doubt that the great majority of situations in which a  
right to contribution arises in practice involve several, rather than joint,  
[41] On this basis, one would expect that the motion was dismissed. It was. But not before  
counsel for the Plaintiff had a change of heart. On a subsequent appearance, counsel indicated a  
willingness to make clear that while the position remained that the Crown was liable for all the  
damage suffered, should it be found that others shared the blame, the Plaintiff was seeking an  
award only for the Crown’s proportionate share. This being so there would be no basis for a  
claim for contribution. The motion was dismissed but on the understanding that it was open to  
the Plaintiff to amend the Statement of Claim to make clear that the liability of the Crown was  
limited to its relative degree of fault. An application could then be made for a declaration with  
respect to that relative degree of fault.  
[42] The order was appealed. By the time the appeal was heard, the Statement of Claim had  
been amended to meet the suggestion of the motion judge. Thus, there was no basis for a claim  
46 Ibid at T. 24  
47 R.S.O. c. N.1 Section 1 states:  
Where damages have been caused or contributed to by the fault or neglect of two or more  
persons, the court shall determine the degree in which each of such persons is at fault or  
negligent, and, where two or more persons are found at fault or negligent, they are jointly and  
severally liable to the person suffering loss or damage for such fault or negligence, but as  
between themselves, in the absence of any contract express or implied, each is liable to make  
contribution and indemnify each other in the degree in which they are respectively found to be at  
fault or negligent.  
48 Drady v. Canada, supra (fn. 21) at para. 62  
49 Ibid at para. 64  
Page: 13  
for contribution. The appeal was dismissed. The Court of Appeal took it that the motion judge  
had struck the Claim and that he was right to do so.50  
[43] This is another limitation as to what can be accomplished in this trial. The Court of  
Appeal, in dealing with the Third Party claim, observed that the Court maintains the jurisdiction  
to apportion fault against a person not a party to the action or, as put by the Court of Appeal:  
“…nothing in the language of s. 1 [of the Negligence Act51] precludes a court from doing so.”52  
No one is asking for this kind of apportionment. In this situation it would not be appropriate as a  
common issue. The answer would be, or could be, different for every member of the class  
depending on who was involved and what role they played. Thus, all that can happen in this  
common issues trial is the recognition that there was a duty of care owed and that it was, or was  
not, breached. Nothing can be done to assess the degree of fault or the proportion of the liability  
attributable to any party. Still it seems not unreasonable to propose, as a possibility, that once  
any liability of the manufacturer, distributor, doctors, hospitals and others are accounted for, any  
degree of liability attributable to the government might be small, in relative terms and as to its  
[44] Another limitation is in respect of the class. How many people are there who could  
benefit from a finding in favour of the class? Not many.  
[45] How was the class to be defined?  
…The classes that the plaintiffs seek to represent consist of persons resident in  
Canada, outside British Columbia and Quebec, who received the TMJ implants.53  
[46] This is a highly generalized statement. A true understanding of the class requires  
refinement. I begin by repeating that the reason Kevan Drady’s individual action failed is  
because he was unable to identify Vitek Inc. as the manufacturer of the implant he had received:  
In this case, although the allegations relied on by the plaintiff appear to relate to  
the same implants (Vitek Proplast implants) of the same vendor/importer whose  
breaches of duty were allegedly ignored by the Crown in Baric, it is not pleaded  
that Mr. Drady received any such implant.54  
[47] This class action concerns those who received Vitek Inc. Proplast temporomandibular  
joint (jaw) implants. What follows from Drady is that if the individual did not receive one of  
these implants, he or she cannot be a member of the class:  
50 Taylor v. Canada (Health), 2009 ONCA 487 (CanLII), 95 OR (3d) 561, 309 DLR (4th) 400, 264 OAC 229,  
[2009] OJ No 2490 (QL)  
51 R.S.O. 1990 c N.1  
52 Taylor v. Canada (Health), supra (fn. 50) at para. 27  
53 Drady v. Canada, supra (fn. 21) at para. 1  
54 Ibid at para. 22  
Page: 14  
It follows that the scope any duty of care that might exist between the Crown and  
those who received the Vitek Proplast implants cannot, in my opinion, extend to a  
person who did not receive them.55  
[48] Understood in this way, membership in the class is narrowly defined: implants made by a  
particular manufacturer, utilizing a proprietary product in its manufacture (Proplast), implanted  
without the requisite acceptance by the regulator (the granting of a Notice of Compliance), where  
the recipient or his caregivers were misled into believing a Notice of Compliance had been  
granted when they had not been, or, in circumstances where the Notice of Compliance, though  
issued, should not have been.  
[49] All of this when the suggestion is that there were few of these implants used in Canada.  
There have been doubts about the numbers since the beginning. The following paragraph appears  
in the reasons responding to the first certification hearing, the one that took place during June  
2007 with the decision being released on September 5, 2007:  
Plaintiff's counsel estimated the size of the class to be approximately 2600  
individuals. The evidence in support of a number this large is not persuasive. The  
estimate is based on information from Health Canada that 26,000 Vitek TMJ  
implants were distributed in the United States and an assumption that, based  
simply on the relative populations of Canada and the United States, "it would not  
be unreasonable" to conclude that 2,600 units were implanted in Canada. The  
information from Health Canada on which counsel relied only in part suggests  
that the class might not exceed 200 persons.56  
[50] To the Court of Appeal, at the hearing of the special case, the assumption was that the  
group was small:  
In my view, it is arguable that the misrepresentations, combined with the failure  
to correct that misrepresentation in the face of knowledge of the serious and  
ongoing risk posed to a clearly definable and relatively small group of consumers,  
could be viewed as akin to the regulator's failure in Fullowka to act in the face of  
the known and ongoing dangers posed to the small and well-defined group of  
miners who worked in the specific mine which the regulator knew to be unsafe.57  
[51] This perception is fundamental to the ultimate determination made by that Court. The  
finding that it was not plain and obvious that the action could not succeed was based on the  
understanding that the interaction that was the foundation of the required proximity was to other  
than those affected by the regulator’s regular work, by definition a smaller group. Inspite of all of  
this, as late as November 27, 2018, a motion was brought before Master McGraw who, while  
acknowledging that some members would have died, understood the size of the class to have  
55 Ibid at para. 25  
56 Taylor v. Canada (Health), supra (fn. 17) at para. 60  
57 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 111  
Page: 15  
“approximately 2500 -2600 members.58 The Submissions of the Plaintiff made at the end of the  
trial use the same estimate.59  
[52] As will become apparent later in these reasons, there is some reason to wonder whether  
any of the individuals who testified are, in fact, members of the supposed class. This leaves open  
the prospect that there is no class.  
[53] There are serious limitations to the impact of any decision the Court may render. There is  
only a narrow route to the necessary proximity; it is only the alleged negligence of the Crown  
that is at issue, its proportionate share of liability, if any, cannot be determined as a common  
issue and the size of the class cannot be determined but could be small.  
[54] In this consideration of the history, I move on to production. This was an issue of  
controversy throughout the twenty years leading to this trial which continued, despite the efforts  
of the Court to bring it to an end, up to and including the last days of the trial. It does not reflect  
well on the parties, either of them. To my mind, it contributed substantially to the delay in  
bringing this matter to resolution.  
[55] On October 17, 2003, Master MacLeod released reasons in a motion dealing with  
production.60 Viewed from the perspective of the time (the beginning of the process) it was both  
comprehensive and prescient. It concerned the fundamental obligations of the Crown:  
(1) Was it obliged to swear an affidavit of documents in the usual form?  
(2) What was the range of documents to be produced?61  
(3) Given the volume of documents to be produced and the production of copies on  
CD ROM, what special rules should apply?62  
58Taylor v. Attorney General of Canada, 2018 ONSC 7235 (CanLII) at para. 7  
59 Submissions of the Plaintiff at para. 3  
60 Logan v. Harper, 2003 CanLII 15592 (ON SC),  
61 Ibid at para. 3(b):  
type of TMJ implant apparently used in the plaintiff’s jaw?  
ii) For the purpose of these cases, what are “documents” and is it necessary to disclose file  
Are all documents relating to TMJ implants relevant or only those relating to the specific  
folders, file folder tracking information and other documents disclosing who had possession of  
or access to particular files at specific times?  
is there only an obligation to disclose relevant documents retrieved from files?  
iv) What is the extent of the obligation to provide a complete and comprehensive Schedule  
Are files in their original form and order “documents” within the meaning of the rules or  
C to the affidavit or list of documents?  
62 Ibid at para. 3(c) a list was provided, as follows:  
Should the defendant be required to share its software for searching the CD ROM  
version of the documents?  
Page: 16  
(4) Should Health Canada disclose how the search for documents was conducted,  
who conducted it and what search criteria were used?  
[56] In answering the questions that were put to him, the Master made an observation pointing  
to the problem the parties faced:  
A large document case, requires a specific plan for organized access to the  
documents. Tracking document locations and permitting inspection of originals is  
particularly problematic if the documents or files are required for the day to day  
operations of an organization or if they may be subject to production in more than  
one proceeding and may be required in the future. In such situations, the  
immediate production obligation must be balanced against the need to maintain  
the ongoing viability of the filing system. Production obligations can be onerous  
and disruptive to an organization and some balance must be struck.63  
[57] He made plain the risk and advised as to the solution:  
Finally, to avoid complete chaos on both sides, the organization and production of  
the documents for the purpose of the litigation should ideally utilize a jointly  
accepted plan of organization, authentication, identification and retrieval. What is  
necessary therefore is definition of the scope of production, a production  
procedure that is understood and accepted and liberal doses of procedural  
collaboration and common sense. In these actions, I invite counsel to agree on the  
plan but if agreement cannot be achieved, court management and supervision of  
the production and discovery process appears necessary.64  
[58] The Master understood that, in this situation, there were practical limits to the process:  
The plaintiffs wish paper copies of every document and wish to inspect every  
original document. As I understand it they also wish to see every document in its  
original file folder in original order and they wish production of the file tracking  
documents or stamps which are believed to show who within Health Canada had  
possession of any file and at what time. In the particular circumstances of this  
case with the volume of documentation involved, that demand is unrealistic,  
onerous, expensive and excessive. It is unnecessary for every document to be  
subjected to this level of scrutiny. There is a right to inspect original documents  
Notwithstanding the production of scanned, indexed and potentially text searchable  
versions of the documents, is the plaintiff entitled to insist upon inspection of every original  
Must Health Canada provide paper copies of the documents in addition to the CD ROM  
63 Ibid at para. 27  
64 Ibid at para. 27  
Page: 17  
and there may be relevance to file tracking information or file organization but it  
is necessary for such rights to be exercised in a focussed and targeted manner.65  
[59] All of which speaks to the clear-headed observation that some cooperation and  
understanding needed to be applied to the difficulties of this particular document search.  
[60] Fifteen years later, on October 29, 2018, a motion was brought before Master McGraw.  
The motion was, in part, for an order striking out the Statement of Defence for “…the alleged  
failure to produce documents pursuant to court orders, specifically the order of Master MacLeod  
(as he then was) dated October 17, 2003”.66 This was taken in the face of a trial date that had  
been set by Mr. Justice Firestone, a year earlier, on October 31, 2017. The Master was aware of  
the problematic nature of this request. He wondered if some other remedy, one that would allow  
the action to continue to trial, had been considered. He was advised that a proposal had been  
made by the Plaintiff and rejected by the Crown. The motion began. Counsel for the Plaintiff, at  
the conclusion of his submissions (approximately three hours into the motion) changed his  
position. He advised the Court that rather than the striking of the defence, the Plaintiff was  
seeking an order requiring further production including examination of a non-party, a former  
employee of Health and Welfare Canada. The Crown was unable to respond. It had prepared to  
answer what the Master referred to as the Plaintiff’s “aggressive and exclusive pursuit of  
dismissal of the Defence”.67 The Master was confronted with a problem. As he saw it, even if the  
Court was to make the order on that day, it was not practical to expect that it could be complied  
with by the trial date that had been set, January 14, 2019:  
Given the age and volume of the documents sought, some of them over 30 years  
old and others which may no longer exist or are in dated electronic format that  
must be located and searched, I am not satisfied that all steps contemplated by the  
Proposed Order can even be completed in time for trial, let alone in time for any  
documents produced or examination transcripts to be used as evidence at trial.  
Further, if the Defendant wishes to oppose certain terms of the Proposed Order, it  
is entitled to additional time to properly respond to the Plaintiff’s change of  
position and the late filed materials. All of this must be balanced with the  
Plaintiff’s entitlement to relevant documents prior to trial, particularly in a  
procedurally and substantively complex matter such as this.  
[61] It seems there was the risk of a further motion seeking a further examination:  
Further, there is still the possibility that the Defendant will be bringing a motion  
to examine Dr. Blais68  
65 Ibid at para. 28  
66 Taylor v. Attorney General of Canada, 2018 ONSC 6808 (CanLII) at para. 1  
67 Ibid at para. 7  
68 Ibid at para. 8  
Page: 18  
[62] The Master, relying on rules 37.02(2)(b) and 1.04 adjourned the motion sine die (without  
a day), and returned the matter to Mr. Justice Firestone for directions with respect to the fixed  
trial date, the motion and the changed relief being sought by the plaintiff.  
[63] Justice Firestone issued a procedural order on November 5, 2018. A new trial date was  
set, April 1, 2019, peremptory to all. The parties were ordered to attend before Master McGraw,  
on November 27, 2018 and November 29, 2018, for the return of the motion. To ensure there  
were no further delays, Mr. Justice Firestone added as a term of his order that there were to be no  
further motions prior to trial other than those that might be heard by the trial judge.  
[64] The motion was brought back before the Master who released his reasons on December  
3, 2018. There were no fewer than ten motions (eight by the plaintiff, two by the Crown), all  
dealing with production and requests for further examinations.69 The situation confronting the  
Master was complicated by the history and the circumstances:  
69 Ibid at para. 1:  
the Plaintiff’s motion to compel the AGC to locate and produce copies of all versions of the report  
prepared on May 28, 1981 by Dr. Pierre Blais, the Plaintiff’s key witness and a former research scientist in  
Health Canada’s (“HC”) Medical Devices Bureau from 1976 until 1989, entitled “Plastic Fluid Handling  
Systems and Implanted Devices: Rationale for regulatory amendments” (the “1981 Report”) together with  
audit trails and search parameters as evidence of such efforts;  
the Plaintiff’s motion to compel the AGC to locate and produce electronic versions of all  
documents for which the AGC disputes authenticity;  
the Plaintiff’s motion to compel the AGC to locate and produce publication and/or presentation  
approval sheets for all papers prepared by Dr. Blais together with the underlying documents submitted in  
support of such approval requests;  
the Plaintiff’s motion to compel the AGC to produce Dr. Blais’ personnel file;  
the AGC’s motion to compel the production of Dr. Blais’ original documents for forensic  
the AGC’s motion to compel answers to undertakings and refusals arising from the examination of  
Dr. Blais on September 26, 2018;  
the Plaintiff’s motion for the continued examination for discovery of Dr. William Freedland on  
refusals from his discovery and questions properly arising therefrom, or, in the alternative, an order that Dr.  
Freedland be examined pursuant to Rule 31.10;  
the Plaintiff’s motion to take the evidence of Dr. Napke, Dr. Neville, Dr. Blais and Kathryn Taylor  
before trial pursuant to Rule 36.01;  
the AGC’s motion for the examination of Dr. Blais pursuant to Rule 31.10; and  
the AGC’s motion to take the evidence of Francine Jacques and Dr. Noel Rose prior to trial  
pursuant to Rule 36.01.  
Page: 19  
These 10 motions proceed in less than ideal circumstances. This is a 19-year,  
procedurally and substantively complex class proceeding where the parties have  
been engaged in ongoing production disputes for over 15 years. The documents  
produced and sought are voluminous with many of them over 30 years old and  
some even over 40. Some documents may no longer exist, previous searches may  
not have located them and the potential places to search for documents is  
overwhelming. Combined with the fixed peremptory trial date of April 1, 2019,  
this strikes at the heart of proportionality and requires a balancing of the parties’  
entitlement to know the case they must meet through the production of relevant  
documents and right to oral discovery prior to trial and the efforts and costs  
imposed on the other party. Quite simply, there is not enough time until trial to  
complete the additional, comprehensive procedural steps which the parties seek  
and which would be ideal for a case of this nature in the current circumstances.70  
[65] Master McGraw recognized that there had been delay, that both parties were at fault:  
With the volume of available and searchable documents and a trial commencing  
in 4 months, it is not possible to reconcile all of the parties’ positions and  
allegations with respect to the Production Motions. They have not been resolved  
over the last 15-plus years and there is no time to resolve them now. Both parties  
must bear responsibility for the delayed, late and inadequate productions over the  
last two decades and no purpose would be served in determining who is more to  
blame at this time. This includes issues arising from the AGC’s alleged and/or  
apparent non-compliance with the 2003 Order and Master Haberman’s directions  
and the Plaintiff’s late delivery of documents in the possession of her key witness  
19 years into the proceedings and 21 years after his involvement with related  
actions. It is also inevitable that the de-certification, appeal and related pleadings  
amendments have also contributed to the delays and complexity of these  
proceedings. In my view, any allegations regarding the sufficiency, timing and  
propriety or production are more appropriately issues for costs, either on these  
motions or at trial, together with whatever conclusions or inferences the trial  
Judge may draw generally. Allegations of spoliation are more appropriately an  
issue for the trial Judge in any event (Muskoka Fuels v. Hassan Steel Fabricators  
Ltd., [2009] O.J. No. 4782 (S.C.J.) at paras. 5-7).71  
[66] Master McGraw considered each of the ten motions. The decisions he made ordered  
some targeted searches and some specific searches; some to be done electronically, with the  
provision of a description in each case of the Crown’s best efforts including where it searched,  
the search terms; and at least one physical search (material associated with Pierre Blais). Orders  
were made requiring two witnesses (Pierre Blais and Francine Jacques (Gaudette)) to be  
examined, one in Toronto and the other in Montreal, and for the Plaintiff to submit  
interrogatories to be answered by various of the Crown’s employees (Dr. Freedland, Dr. David  
70 Taylor v. Attorney General of Canada, supra (fn. 58) at para. 5  
71 Ibid at para. 21  
Page: 20  
Taylor and Lindsay Blaney). Time limits were imposed: 45 days for some of the items ordered,  
by February 28, 2019 for others and 60 days for the interrogatories.  
[67] What is clear is the intention of both Mr. Justice Firestone and Master McGraw that this  
would be the end of what had been an ongoing dispute concerning production. It was not. On  
March 19 and 20, 2019, less than two weeks before the trial was to begin, the Crown produced a  
book of fresh documents. Counsel for Plaintiff submitted he had been asking for some of them  
over an extended period of time. Not surprisingly, the Plaintiff complained. This required an  
appearance on March 22, 2019. Counsel for the Plaintiff cited the long history of attempts to get  
complete production from the Crown. Counsel asked for an adjournment. Counsel for the Crown  
acknowledged that some of the documents should have been produced earlier but also suggested  
that the Plaintiff was already aware of some of those that were the subject of this late production.  
The adjournment was refused. A series of directions were provided to overcome the difficulties  
the situation presented. Among them, that of the documents that were the subject of the motion,  
the only ones that could be produced at trial were those the Plaintiff agreed to or those the  
Plaintiff indicated an intention to rely on.  
[68] There was a further and subsequent complaint. During March 2018 the Plaintiff produced  
some documents from Dr. Pierre Blais. He had had the documents for at least 30 years. The  
Crown had indicated an intention to question the authenticity of certain of those documents. This  
was among the ten motions heard by Master McGraw and considered by him in his reasons of  
December 3, 2018. Expert reports were referred to. The Plaintiff did not have them. This  
spawned another request for an adjournment by the Plaintiff. The adjournment was refused but  
the issue delayed to be dealt with after all the other evidence was completed, if the Crown  
remained intent on raising the issue.  
[69] As late as September 13, 2019, the Friday before the trial was to resume following a ten  
week break, with only one defence witness remaining to be called, counsel for the Plaintiff wrote  
to the Court seeking a motion for directions for, among other things, production and  
examinations surrounding the issue of the authenticity of the impugned documents of Pierre  
Blais. Counsel for the Crown responded by letter, the same day, sparking a response, in turn,  
from counsel for the Plaintiff which included the following paragraph:  
Mr. Gaudet’s letter revives the Plaintiff’s concerns about the AGC’s continuing  
non-compliance with prior production Orders. This noncompliance vitiates the  
Plaintiff’s ability to advance her case. Relevant documents were and continue to  
be withheld from production and discovery. Trial fairness cannot be restored  
without focussed remedial relief and sanction.  
[70] I have reviewed the letter from Mr. Gaudet. I am hard pressed to understand how it would  
be a catalyst for going back to Master MacLeod’s order of October 17, 2003. It does not matter.  
What this exchange demonstrates is that to the very end, 16 years after the order of Master  
MacLeod, the parties continued to battle over productions. Like Master McGraw I see no  
purpose in trying to assess blame. I say only that it is clear that the injunction of Master  
MacLeod, that cooperation was required, was not adhered to. This was to the detriment of the  
parties and to the proceeding.  
Page: 21  
[71] Out of the history of this proceeding and its certification was the identification of the  
common issues to be dealt with in this trial. They are:  
(1) Did Canada owe a duty of care to class members?  
(2) If so, did Canada breach the applicable standard of care?  
(3) If so, can Vitek Proplast temporomandibular joint implants cause injury to those  
receiving them?  
[72] The Food and Drugs Act was passed in 1920. Statutory provisions specifically dealing  
with medical devices were first enacted on May 14, 1953 and came into force on August 16,  
1954.72 The Food and Drugs Act was introduced at the material time, as it is now, as “An Act  
respecting food, drugs cosmetics and therapeutic devices”.73 What is a “medical device”? The  
Food and Drugs Act did defined the term “device”:  
“device” means any article, instrument, apparatus or contrivance, including any  
component, part or accessory thereof, manufactured, sold or represented for use in  
(a) the diagnosis, treatment, migration or prevention of a disease,  
disorder or abnormal physical state, or the symptoms thereof, in  
man or animal,  
(b) restoring, correcting or modifying a body function or the body  
structure of a man or animal,  
(c) the diagnosis of pregnancy in humans or animals, or  
(d) the care of humans or animals during pregnancy and at and  
after birth of the offspring, including care of the offspring,  
and includes a contraceptive device but does not include a drug.74  
[Emphasis added]  
[73] For the purposes of these reasons, we are concerned with subparagraph (b).  
Temporomandibular joint implants replace the meniscus that separates two elements of the jaw,  
the fossa and the condyle, to allow for its proper movement.75  
72 Agreed Statement of Facts at para. 13  
73 R.S.C. 1985 c. F. 279 (The definition has since been amended)  
74 R.S.C. 1985 c. F. 27 at s. 2  
Page: 22  
[74] Beginning in December 1954 and through August 1975 deviceswere also subject to  
the provisions of the Food and Drug Regulations. The concern for and interest in the regulation  
of medical devices galvanized in and around 1975. This was occasioned by two unfortunate  
examples: the Dalkon Shield, an intrauterine contraceptive device, and the nuclear batteries  
utilized in pacemakers inserted into the heart. The former caused infection; the latter  
disintegrated in the body. A third factor was the “beginning of intraocular surgery”.76 As a result,  
on September 2, 1975, the Medical Devices Regulations, a regulation specific to these devices,  
was introduced.77 Among other things, the Medical Devices Regulations govern the entry of  
devices into the market in Canada. From the outset, the Medical Devices Regulations prohibited  
the importation into Canada of any device the sale of which would violate any part of the Food  
and Drugs Act or the Medical Devices Regulations.78 On March 25, 1977, a limited form of pre-  
market review was introduced into the Medical Devices Regulations.79 It was restricted to “new  
devices”. “New devices” were, and remain in the current version of the regulations, defined as:  
“new device”, in relation to a manufacturer, means a device listed in the table to  
this Part that  
(a) has not been sold previously in Canada by that manufacturer,  
(b) it is, in respect of any characteristic, different from any device  
sold previously in Canada by that manufacturer, or  
(c) is, in respect of all characteristics, identical with a device sold  
previously in Canada by that manufacturer that has previously  
been recalled or withdrawn from the market or that he has ceased  
to manufacture or sell.80  
[Emphasis added]  
[75] As of the promulgation of the Medical Devices Regulations on March 25, 1977, the  
“device[s] listed in the table to this Part” included only: (1) Intra-uterine devices and (2) Cardiac  
75 The Agreed Statement of Facts at para. 42 describes the temporomandibular joint as follows:  
The TMJ is comprised of the condylar head of the mandible, the glenoid fossa of the temporal  
bone and an interposed articular disc. Additionally, these structures are supported by a joint  
capsule and ligaments and are connected to the muscles of mastication.  
76 Transcript of Pierre Blais (April 26, 2019) at pp. 49-51  
77 Consolidated Regulations of Canada (1978) Volume VIII, Ch 871  
78 SOR/75-526 at s. 15 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 at s. 16:  
Subject to section 19 [subsequently s. 20], no person shall import into Canada for sale a device  
the sale of which in Canada constitute a violation of the Act or these Regulations.  
79 Agreed Statement of Facts at para 18 referring to Medical Devices Regulations, amendment SOR/77-258,  
Schedule II, s.28  
80 SOR/77-258 at s. 28 (in the current consolidated regulation s. 32)  
Page: 23  
pacemakers. A manufacturer of a “new device” was prohibited from selling or advertising that  
device unless the manufacturer received a Notice of Compliance from Health and Welfare  
Canada. To obtain a Notice of Compliance, the manufacturer was required to submit to Health  
and Welfare Canada evidence establishing the safety and efficacy of the new device. On October  
8, 1982, the Table to Part V of the Medical Devices Regulations was amended to extend the pre-  
market review to any “new device” designed to be implanted into the tissues or body cavities of  
a person for 30 days or more.81 This amendment became effective on April 1, 1983. From this, it  
is apparent, and it was not disputed, that what in 1977 was Part IV of the Medical Devices  
Regulations and is now Part V applied to the Vitek Proplast Implants that are at the centre of this  
proceeding. To be clear it was understood and accepted by all parties that in order to be  
mandated for sale in Canada these products required Notices of Compliance. It should be said  
that a Notice of Compliance allows the product involved to be sold and used in Canada.  
However, it signifies only that the submissions made in support of the application “complied”  
with the legislative requirements. A Notice of Compliance is not a statement by the government  
that the product is safe, only that the work required to justify its entry into the Canadian market  
according to the tests set out in the Medical Devices Regulations has been completed. In short, a  
Notice of Compliance is not a guarantee, by the government, that the device is safe for use and  
will assist in reducing pain or benefit the problem being treated. The review it conducts is as to  
the sufficiency of the work; it is not a peer review as to how it was conducted or a replication  
that confirms the results. The legislation makes clear that the responsibility to conduct proper  
studies lies with the manufacturer.  
[76] At the time the submissions seeking Notices of Compliance for the products of interest to  
this case were made there was some suggestion, by those applying, that the product had been  
“sold previously in Canada” and that they should be “grandfathered” and not treated as “new  
devices”. Documents that purported to confirm those sales were not accepted as such by the  
representatives of Health and Welfare Canada. As the Plaintiff has asserted, and as the Defendant  
has readily conceded, they had to be treated as they were, that is, as new devices to which the  
requirements of Part V of the Medical Devices Regulations applied.  
81 Agreed Statement of Facts at para. 21 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 and  
Medical Devices Regulations, amendment SOR/82-914:  
The table to Part V of the Medical Devices Regulations is revoked and the following substituted  
3. Any device designated to be implanted into the tissues or body cavities of a person for 30 days  
or more.  
Page: 24  
[77] There were criteria applicable to the content and assessment of the submissions made to  
support the request for any Notices of Compliance for “new devices”. Under the heading:  
Submission” the Regulation noted:  
s. 35(1) For the purpose of obtaining a notice of compliance, the manufacturer of  
a new device shall submit to the Director  
evidence of the safety of the device consisting of at least  
the name and mark under which the devices to be sold,  
the purpose of the device and its method of use,  
the performance characteristics of the device,  
the specifications and limits set for those materials of the  
device that may come in contact with body tissues or fluids and a  
summary of the test methods used to ensure conformity with those  
specifications and limits,  
if sold as sterile, the method of sterilization and the  
recommended method of resterilization, if applicable,  
a general description of the plant, equipment and  
procedures used in the manufacture of the device,  
(vii) the quality control program and procedures used ensuring  
manufacturing, packaging and sterilization of the device, and  
(viii) that full data of all chemical studies, analysis and animal  
studies carried out to determine the bio-compatibility of those  
materials of the device that may, in the normal use, come in  
contact with body tissues or fluids;  
evidence of the effectiveness of the device, consisting of at least  
the results of all clinical trials to show the effectiveness of  
the device,  
where clinical trials have not been made, the results of  
animal studies or appropriate tests that demonstrate a probability of  
effectiveness in humans, and  
(iii) all known adverse reactions or contra-indications to the use  
of the device under the recommended conditions; and  
Page: 25  
drafts of all labels, package inserts, product brochures and file  
cards to be used in connection with the device.  
(2) Where the Director is of the opinion that the evidence and materials submitted  
by a manufacturer pursuant to subsection (1) are not sufficient for him to  
determine whether or not he should issue a notice of compliance for the purpose  
of selling or advertising the new device, the Director may require the  
manufacturer to submit to him further information concerning the device or any  
samples of any of the ingredients or components of the device and of the device  
[78] Under the heading: “Issue of Notice of Compliance”:  
s. 36. Within sixty days after the latest date of the receipt by the Director of  
evidence, materials or information submitted by a manufacturer under section 35,  
where that Director is satisfied that the manufacturer has provided  
substantial evidence that  
the conditions of production and quality control are suitable for  
controlling the quality, stability, safety and performance of the new  
the new device can be used for the purpose and under the  
conditions of use recommended by the manufacturer without undue risk to  
(iii) the new device is clinically effective for the purpose and under the  
conditions of use recommended by the manufacturer or that sufficient animal  
studies have been carried out to establish a probability of effectiveness in humans,  
the drafts of all labels, package inserts, product brochures and file  
cards to be used in connection with the device are adequate,  
the Director shall issue to the manufacturer a notice of compliance; or  
where that Director is not satisfied that the manufacturer has provided the  
evidence referred to in paragraph (a), the Director shall refuse to issue a notice of  
compliance and shall notify the manufacturer of his refusal and of the reasons  
82 SOR/77-258 s.31 and s. 32 (in the current consolidated regulation s. 35 and s. 36)  
Page: 26  
[79] Accordingly, the regulation, in the form applicable when the requests for Notices of  
Compliance were made, first in 1987 and again in 1988, continued to require a demonstration of  
both “safety” and “efficacy”. As was acknowledged by at least two witnesses called by the  
Plaintiff83, these two requirements do not stand as independent standards to be treated and  
considered separate and apart, one from the other. They are not absolute tests measurable on a bi-  
lateral basis: either safe or not safe; either effective or not effective. Instead they function as two  
ends of a spectrum: at one end devices which are safe but do nothing to alleviate the illness or  
disfunction which requires treatment, and at the other end, devices which may cure the concern  
but at the price of some other undeniable harm. Obviously, neither of these two extremes would  
generate the issuance of a Notice of Compliance. The determination of whether to issue a Notice  
of Compliance is a consideration of where, on the continuum between these two extremes, taking  
into account the degree and likelihood of relief measured against the risk of further harm, the  
predicted functioning of the device may fall and whether on that basis it is appropriate to issue a  
Notice of Compliance:  
Q. And we hear the terms evidence of safety and efficacy throughout the last  
month. Can you give us your overview of what that means?  
A. Safety and efficacy are the two essential attributes that are demanded of a  
medical device, offered up matter of drug as well. It is a quantity that is measured  
against the importance of the need that it fulfills. For example, a product can be  
highly efficacious and very safe, but totally useless medically. Conversely a  
product can be extremely dangerous and would have a strong possibility of being  
an inefficacious but is essential surgically. The balance between the two is the  
area that we are now discussing.84  
[80] What this demonstrates is that there is no, and can be no, certain or definitive answer. It is  
a balancing and, thus, inherently contains a high degree of discretion and consideration specific  
to the individual case.  
[81] The limitation imposed by the regulation sets the context in which the choice is to be  
made. There is a time limit. The decision is to be taken within 60 days. This is not much time to  
consider the kind of detailed studies new approaches to science and treatment, by their nature,  
require. Hence the proposition that the determination to be made is not as to the rectitude of the  
studies but as to whether they comply with the regulations that govern these submissions.  
[82] The evidence shown by the studies was required to be “substantial”: first in showing  
“safety” measured as use “without…undue risk” and second, either clinical efficacy (efficacy  
demonstrated through trials on humans) that shows the device to be effective under the  
conditions of use recommended by the manufacturer or efficacy shown through animal studies  
that establish a probability of effectiveness in humans.  
83 Transcript of Pierre Blais (April 26, 2019) at pp. 71-73 and Transcript of Richard Lawuyi (May 27, 2019) at  
84 Ibid (Pierre Blais) at p. 71  
Page: 27  
[83] The answer as to whether a Notice of Compliance should be issued is to be arrived at  
within the time frame set and consistent with the standards to be met. Finding the balance  
between “safety” and “efficacy” reflects on the two competing policy values at the core of the  
regulatory scheme. On the one hand, our desire to have those in the industry find, develop and  
produce devices that will assist those who are suffering and on the other to avoid causing more  
harm. Later in these reasons I will be referring to “Cotrel rods” which were, and may still be,  
implanted in some, particularly teenagers, to assist in remedying curvature of the spine. Surgeons  
complained because these devices could not be sold and used because the necessary Notices of  
Compliance had not yet been issued. They wanted to help their patients. They had to wait for the  
issuance of a Notice of Compliance that was first refused pending the delivery of more  
information and later granted. On the other hand, it is generally known (I believe I can take  
judicial notice) that Dalkon Shields which were made available for sale were not sufficiently  
tested and caused considerable damage. The policy formulation is directed to avoiding both these  
results but inevitably will not always succeed. Heather Sheardown is a Professor in the  
Department of Chemical Engineering at McMaster University. I will say more about her  
qualifications later in these reasons. For the moment I only point out an example she provided  
where despite the best intentions, the balance failed. A cornea transplant was approved by the  
Federal Drug Administration in the United States in 2001. It was received by thousands of  
patients. By 2007 the failure rate of 50% became widely known. Some patients went blind.  
Heather Sheardown noted that in many cases we simply do not know what the long-term impacts  
of these new medical devices will be.85 Nirmala Chopra, who was for a time, in charge of the  
premarket review of medical devices, advised the court that there was an expectation that some  
new devices would cause some difficulty and that generally they would be identified within the  
first five years of any new device entering the market.  
[84] Proplast is a trademark that is used to describe a family of composite materials that were  
designed, manufactured and sold by Vitek Inc., a Houston-based company founded by Dr.  
Charles Homsy in 1969.86 Proplast is composed of a fluorocarbon polymer matrix and a  
reinforcing material, such as fibre or powder. The fluorocarbon polymer matrix includes  
Polytetrafluoroethylene (“PTFE” commonly referred to as Teflon) and may include Fluorinated  
Ethylene Propylene (“FEP”) polymers and/or fluorocarbon polymer fibres. The reinforcing fibres  
or powder may be an organic or inorganic material, including carbon fibre, aluminum oxide or  
hydroxyapatite. The added fibres or powder are intended to provide enhanced mechanical  
strength while the fluoropolymer is intended to provide a chemically inert, continuous host  
material, or polymer matrix.87  
[85] Proplast has been produced in at least three standard types: Proplast I (PTFE/carbon  
competent material), Proplast II (PTFE/aluminum oxide competent material) and Proplast HA  
85 Transcript of Heather Sheardown (May 30, 2019) at pp. 45-46  
86 Agreed Statement of Facts at para. 43  
87 Agreed Statement of Facts at para. 44 referring to Exhibit 8: Expert Report of Dr. Christopher K. Ober, August  
24, 2018  
Page: 28  
(PTFE/hydroxyapatite competent material).88 Proplast has been manufactured in a variety of  
forms including films, sheets, blocks and coatings. In each case, Proplast may be different –  
different composition, different manufacturing processes and different physical and chemical  
properties.89 All types of Proplast have in common soft PTFE fluorocarbon polymer resin and  
fibre that dominate their surface properties and form a porous matrix. The Proplast types are  
distinguished by differences in the filler that lead to differences in mechanical and other physical  
properties between the Proplast types.90  
[86] The Plaintiff does not agree that the various Proplast products are different. Relying on  
the evidence of Elliot Wayne Tunis, a physician who had implanted Vitek Proplast  
temporomandibular implants, the Submissions of the Plaintiff (the written submissions presented  
on her behalf at the conclusion of the trial) note:  
There was no difference between the Proplast IPIs and Proplast sheeting with  
Teflon laminated to it, other than that the IPIs were manufactured from these  
sheets by cutting the sheet into an anatomic size.91  
[87] What is important is that for the purpose of regulating the devices in issue, those  
responsible for premarket review of the many Proplast products saw differences. As we shall see,  
the complaint made at the time the first applications for Notices of Compliance were received  
was that they had been lumped together such that it was not possible to attribute the supporting  
data to the specific devices to which it applied. The applications were refused. When a second  
attempt was made, the same concern arose. Eventually the regulator (not the applicant) organized  
the devices into eight groups, presumably to assist Vitek Inc. Even so, as will become apparent,  
the various Vitek Proplast products were treated differently. Some were issued Notices of  
Compliance (Proplast Block and Sheeting); many were not (Proplast IPI’s).  
[88] Proplast was used as a material component of temporomandibular joint implants  
produced by Vitek Inc. and available to Instrumentarium Inc. to be distributed in Canada.  
Proplast was intended to anchor the implant to the upper bone of the temporomandibular joint.  
it’s porous nature and potential for tissue ingrowth were intended as a feature that would  
encourage stability in the temporomandibular joint.92 Over time it became apparent that the  
PTFE (Teflon) included as part of certain forms of Proplast could, after being implanted,  
fragment, delaminate or otherwise be damaged. Debris in the joint from implants could  
contribute to progressive bone degenerative change and giant cell reaction.93 In time there was a  
product recall.  
88 Exhibit 51 at T. 1 (Expert Report of Dr. Doran Ryan, July 28, 2018) at p. 21  
89 Exhibit 8 (Expert Report of Dr. Christopher K. Ober, August 24, 2018) at p 5  
90 Ibid at p. 6-7  
91 Submissions of the Plaintiff at para. 20 in turn footnoting Tunis Transcript page 66. (The evidence of Elliot  
Wayne Tunis was in the form of a Cross-examination conducted in another proceeding. The basis for its acceptance  
as evidence in this trial is reviewed at para. [178] herein.)  
92 Agreed Statement of Facts at para. 48  
93 Ibid at para. 114  
Page: 29  
[89] Science does not tend to develop understanding in moments of immediate and complete  
insight. Rather it evolves over time. Robert Pilliar testified at the trial. He is an engineer by  
training but has worked, taught and studied in the area of medical devices for many years. When  
he first appeared, he seemed to acknowledge this perspective but when called in Reply he  
demurred. As he perceives it, evolution is a process generally applicable in biology. As he sees  
it, science does not evolve so much as it moves through steps.94 For the purposes of these reasons  
such a distinction does not matter. The point is that our understanding of science changes and  
becomes more complete as our knowledge and experience increase. Nonetheless, movement “in  
steps” suggests a linear progression (both forward and backward). Evolution in its current  
understanding is a broader concept. Among its definitions:  
A process of change in a certain direction…a process of continuous change from  
a lower, simpler or worse to a higher, more complex or better state…a process of  
gradual and relatively peaceful social, political and economic advance…a theory  
that the various types of animals and plants have their origin in pre-existing types  
and that the distinguishable differences are due to modifications in successive  
generations… a process in which the whole universe is a progression of  
interrelated phenomena95  
[90] Each of these meanings connotes continuous and gradual change that can occur in a  
variety of circumstances. In this case, in the overall appreciation of the risks and harm associated  
with Proplast, one of the issues raised was whether this potential should have been appreciated  
sooner by Health and Welfare Canada such that entry into the market of any Proplast related  
product, at least for use as temporomandibular joint implants, should never have taken place,  
should have been recalled sooner and patients directly advised of the risks. To analyse this  
proposition (and using what has become a too often used colloquialism) it is important to come  
to an understanding of who knew what and when they knew it.  
[91] The evidence addressing the question of the degree and timing of any understanding  
concerning the usefulness of Proplast products began with Pierre Blais. He was a research  
scientist employed by the Medical Devices Bureau (and its successors) from its inception until  
his departure in 1989. In the context of this trial, he was a controversial figure. From the  
perspective offered by the Plaintiff, Pierre Blais was central to the understanding, within Health  
and Welfare Canada, of Proplast and its dangers. Attention was drawn to meetings and  
conferences he said he attended, papers he wrote, a book he contributed to and warnings he said  
he instilled in more senior officials at Health and Welfare Canada. With a closer look, the idea of  
this pivotal role dissipates in the uncertainty and confusion that accompanied his participation in  
the events he referred to and in the trial. He left his employment with Health and Welfare Canada  
under difficult circumstances. He was terminated for an alleged failure to comply with internal  
94 Transcript of Robert Pilliar (September 23, 2019) at p. 24-25  
95 Merriam Webster’s Collegiate Dictionary, Tenth Edition Copyright 1993  
Page: 30  
policy governing, among other things, release of information to the media.96 He grieved. The  
grievance was settled. He was reinstated but retired a day later.97 He was called as a witness, not  
by the Crown, but on behalf of the Plaintiff. He had been available to the Plaintiff’s counsel for  
many years. Even so, in 2017, he produced documents that had not previously been seen.98 He  
happened on them when going over files he maintained in his home. The authenticity of four of  
these documents was questioned by the Crown. At a pretrial conference during the weeks leading  
up to the commencement of the trial, counsel for the Plaintiff advised they were unprepared to  
deal with the issue. One of the reports on which the Crown sought to rely had not been delivered.  
The Plaintiff required time to retain an expert, prepare a response. This resulted in one of the  
adjournment requests to which I have already referred. This was refused. The issue was set aside.  
The documents in issue were to be admitted without reference to their authenticity. That issue, if  
the Crown still intended to proceed with it, would be heard in a separate proceeding at the end of  
the evidence but before final submissions were made. Although not without difficulty, as the end  
of the evidence approached, that is what happened.  
[92] I will refer to each of the four documents as they become relevant. This is provided at the  
outset of these reasons in response to a proposition put in the “Submissions of the Plaintiff”. It is  
said there that the allegations made against Pierre Blais should be rejected. This is not surprising  
but it is not all that was submitted. Counsel for the Plaintiff goes on:  
But in the aftermath of those findings, the Plaintiff submits that Dr. Blais’  
evidence must be accepted as true. Indeed the AGC resiled from its decision to  
call Health Canada witnesses who would have been in positions to refute Dr.  
Blais’ evidence.99  
[93] In other words, as counsel sees it, if the four documents are found to be authentic, there  
need be no further inquiry into the reliability of what those documents say, or it would seem, the  
value of any of the other evidence provided by Pierre Blais. To my mind, this is wrong in a  
profound way. If the documents are authentic, their reliability, probative value and impact in  
contrast to what others have said would remain open for the Court to examine. I go further. It  
would be a failure of the Court, in carrying out its responsibilities, if it did not do so. If the  
Crown had other relevant evidence that it could have called and chose not to do so, that is a risk  
it took.  
[94] For all of his experience, the Plaintiff did not seek to qualify Pierre Blais as an expert. In  
the Submissions of the Plaintiff, Pierre Blais is referred to as a non-party, lay witness”. He is  
not a party but I am uncertain as to the implication of his being a “lay witness”. It is undeniable  
that he was employed through the material time, by Health and Welfare Canada, at the Medical  
Devices Bureau, through whatever name changes and restructuring that occurred during that  
96 Exhibit 34 at T. 11 (Letter dated July 14, 1989 Dr. A. J. Liston to Pierre Blais.)  
97 Ibid at T. 12 (Settlement Offer)  
98 Transcript of Pierre Blais (May 10, 2019) at p. 425-428 and 442-443  
99 Submissions of the Plaintiff at para. 152  
Page: 31  
period. The meaningful distinction, at least as I understand it, is as a “fact” as opposed to an  
“expert” witness. I take this to be the import of the Submissions of the Plaintiff where the  
following is said:  
The Plaintiff called Dr. Blais as a lay witness because of his first-hand knowledge  
that Health Canada’s middle and senior management knew that Proplast was  
unsafe from the early 1980’s onward.100  
[95] I mention this because much of the evidence of Pierre Blais dealt with the state of  
knowledge concerning Proplast as time progressed. What may be interpreted as fact today may  
not have been understood as such at an earlier time. As will become apparent as these reasons  
proceed, what the Plaintiff, relying on Pierre Blais, believes should have been understood early  
in the progress of these events is not so certain. This is especially so when the evidence of Pierre  
Blais is fully examined and considered in the context of what was said by others. At the time,  
perhaps still, there are experts who do not agree with what the Plaintiff takes to be fact. Some of  
this is better understood, at least at the times in question, as opinions. Nonetheless, so far as I can  
recall (there were 55 days of evidence) not once was the evidence given by Pierre Blais objected  
to as crossing from fact to opinion. I take his evidence to be demonstrative of what he saw as fact  
but which others may have seen differently. I believe this to be consistent with the evidence and  
how it was provided but also sensitive to the understanding that broad scientific acceptance is not  
generally a matter of immediate insight but the result of the sort of evolution that occurs over  
time as experience increases knowledge.  
[96] As explained by Pierre Blais, the Medical Devices Bureau was formed in 1975. It was a  
consolidation of those parts of the Health Protection Branch that were concerned with non-drug  
health care products. Pierre Blais recalled that he was the fifth employee brought into the new  
Bureau.101 The catalyst for this consolidation was the appearance of non-drug medical devices  
(such as the Dalkon Shield, pacemaker batteries and the beginning of intraocular surgery), and  
the need for the responsibility for their regulation to have a home. As depicted by Pierre Blais  
this reorganization was not a well-planned response to the developing concerns. “It was  
opportunistic in a sense. It was done piecemeal. And there was no precedent…”102  
[97] In summer of 1976, Pierre Blais attended a Gordon Conference.103 While the origins,  
source and substance of “a Gordon Conference” was not reviewed, it seems that this was one of a  
series of such conferences covering wide areas of scientific interest. Dr. Charles Homsy, the  
person recognized as the developer of Proplast, made a presentation. It concerned Proplast and  
its properties. Those in attendance were identified by Pierre Blais as “one half of the  
100 Ibid at para. 148  
101 Transcript of Pierre Blais (April 26, 2019) at p. 47)  
102 Ibid at p. 51  
103 At first Pierre Blais recalled this conference as taking place during 1977. However, the program of the conference  
says it was 1976 (Exhibit 34 v. 1 T. 15) as do the notes prepared, at the time, by Pierre Blais (Exhibit 34 v. 1 T. 16).  
(p. 15) see also Transcript of Pierre Blais (May 10, 2019) at p. 483  
Page: 32  
contributors to the biomaterials of tissue and bone in the world104[Emphasis added]. He stated  
his own immediate response:  
I was very disappointed by the lecture, but other attendees had other views.105  
[98] He went on to describe the general reaction of those in attendance. It was more than  
disappointment. It was outrage. As witnessed by Pierre Blais the scene was one of  
“pandemonium.” Charles Homsy was besieged by questions from an audience angered by what  
he was saying. As outlined by Pierre Blais, the expressed concerns included:  
why Doctor Homsy was promoting the use of a product where the components  
were individual carcinogens or collective carcinogens, firstly. The second  
concern was that they were complaining that the mere totality of his formula were  
so irritating that they would produce an outright rejection reaction on simply  
being there. A third concern was that the photographs and the photo micrographs  
that Doctor Homsy had shown before showed the Proplast to be disintegrating and  
they had not discussed this.  
It was the overlying, the fact that the material did not have enough strength to  
remain together and that the debris was being disseminated throughout the tissue  
and the living organism through fluids, such as the lymphatic fluid were the key  
concern to the whole thing and was the basis for why the audience was very  
unfavorably inclined.106  
[99] This evidence was anecdotal. There is no data, analysis, report or reviewable assessment  
of any potential risk on which a regulator could rely in examining the overall value of the  
product. There are some handwritten notes made at the time by Pierre Blais. They include  
negative comments with respect to another of the presenters (“PURE BULL” repeated 13 times)  
but only technical observations insofar as what was said by Charles Homsy.107 Even so, those at  
Health and Welfare Canada took account of what Pierre Blais described. Upon his return he  
reviewed what had taken place with his immediate superior, Dr. Ronald Campbell and the  
director of the Medical Devices Bureau, Dr. Ajit DasGupta. As Pierre Blais recalled, they met  
with the personnel of the Bureau responsible for those devices treated by Part V of the Medical  
Devices Regulations (“new devices”) as well as those responsible for the notification  
requirements applicable to other medical devices.108 The investigation went beyond the Bureau  
104 Transcript of Pierre Blais (April 26, 2019) at p. 123  
105 Ibid at p. 122-123  
106 Transcript of Pierre Blais (April 26, 2019) at p. 124-125  
107 Exhibit 27 v. 3 at T’s A, B, C and D  
108 To my mind there is some confusion in this, given that the amendments to the Medical Devices Regulations  
which introduced the concept of “new devices” did not become effective until March 25, 1977. At the time it was  
introduced, it was Part IV. In any case, the point is that at the time those responsible followed up on the information  
brought back by Pierre Blais from the Gordon Conference of 1976.  
Page: 33  
through telephone calls with, and visits to, parties known to be reliable. A conclusion was  
reached. The product was not being sold in Canada through any recognized means or distributor.  
[100] In the period following the Gordon Conference, Pierre Blais says he continued to raise  
Q. Between 1977 and your ultimate final leaving of Health and Welfare Canada  
at the end of 1989, were you engaged in any debate with any co-worker at Health  
and Welfare Canada of any rank about the safety of Proplast?  
A. Yes.  
Q. With whom?  
A. The mere totality of the early generation of evaluators and then later in formal  
lectures that I would give to other members of the department who were not part  
of the Bureau, specifically, the field operations group. I recollect, and I may even  
have notes about a lecture that I delivered on frangible implants in connection  
with the Montreal group, and in connection also with the Toronto field operations  
[Emphasis added]  
[101] Pierre Blais told the Court that by 1981 there was a common view extant in Health and  
Welfare Canada that the product was “damaging”:  
Q. I’m asking if there was any debate within Health and Welfare Canada that  
there was a safe use or an efficacious use for Proplast?  
A. Such debates did take place, but only in the academic sense. There was  
unanimity in the belief that the product was very much damaging from certainly  
1981 onward, and that was general. It was not just one, one view, or even the  
official view of our directorship, it spread to everybody...110  
[Emphasis added]  
[102] To suggest that there was no one at Health and Welfare Canada who wondered whether  
the product had value is not accurate. Dr. John Orpin, Medical Advisor, Division of Clinical  
Assessment, Bureau of Medical Devices111 voiced a caution that patients not be deprived of  
something useful.112 As put by Pierre Blais this was explained as follows:  
109 Transcript of Pierre Blais (April 29, 2019) at pp. 11-12  
110 Ibid at p. 14  
111 Exhibit 27 v. 3 at T. H (Letter January 17, 1985 (Dr. J.A. Orpin to Dr. M.T. Cooper)  
112 Transcript of Pierre Blais (April 29, 2019) at p. 108  
Page: 34  
John Orpin, who was also a colleague and a co-worker under Dr. Campbell, and  
his comment was that how did he put it he said but what if perchance it has  
some value. By declaring it unsuitable and unacceptable, could we be depriving a  
patient of something that could be useful. But it was not a criticism. It was not  
someone who supported Proplast. Quite on the contrary. He was simply  
advocated that could we possibly have made mistake. It was the only exception.113  
[103] The source of any information that contributed to this “unanimous belief” was Pierre  
Blais. No additional work or research was referred to. There is no suggestion that over these  
years any notification or application for a Notice of Compliance, along with the data that would  
be required with such a submission, was received for any Proplast product, much less for use as a  
temporomandibular joint implant. There is no suggestion that prior to 1981 there were any sales  
or use of Proplast temporomandibular joint implants in Canada.114  
[104] The evidence, taken as a whole, suggests that Pierre Blais did not play the role he has  
defined for himself. Some of the employees at the Health Protection Branch had never met him,  
others say he played no role they are aware of in respect of Proplast and others say his primary  
interest was with the difficulties being encountered with breast implants. There were people who  
disagreed with him. They were referred to by Pierre Blais as dissenters:115  
113 Ibid at p. 107  
114 At Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. 2 T. 84 and Exhibit 73 T. 4 at p. 14 there is reference to two  
Proplast-like knee implants:  
A Canadian Dow Corning representatives [sic]in Montréal recently disclaimed having ever sold  
Proplast products. Reports of unregistered 'clearinghouse' distributors, mail order advertisements  
and commercial irregularities involving Proplast and Vitek have been received. Two cases  
involving implantation of Proplast-like material to the knee were uncovered in the Québec city  
area incidentally to a study on knee surgery….  
With respect to temporomandibular implants the same document notes, at the same page:  
Adverse events surround the use of Vitek Proplast in the US and a controversy has broken out in  
Louisiana dental surgery circles. The Canadian Dental Association was informed about the  
matter. Complications emerge first in situations involving the temporo mandibular joint (TMJ)  
repair. An investigational Vitek implant claimed to be suitable for insertion during a simple  
office procedures is [sic] presently promoted for mild discomfort and noise incidental to  
movement of the jaw. Such a procedure is evidently gaining popularity in the US but may not  
have reached Canada yet. Major problems are expected if and when and if it does.  
The document from which these quotations are extracted is one of the four the authenticity of which is been  
questioned by the Defendant. For the purposes for which these quotations are used here, I point out only that these  
were implants inserted into the knee and not as temporomandibular joint implants. The two knee implants are  
discussed in a handwritten memo dated September 9, 1982 from P. Blais to Dr. M. T. Cooper (Exhibit 27 v. 1 T. 12  
at p. 000069)  
115 Transcript of Pierre Blais (April 29, 2019) at p. 14 (Dissenter recorded in the transcript as “descenders” which I  
take to be a typographical error.)  
Page: 35  
However, there were [dissenters] who were not within the community, who were  
not within Health and Welfare who occasionally advocated that there were  
potential useful applications for Proplast, but they were not National Health and  
Welfare people.  
[105] Who were they? The quotation immediately above is followed by:  
They were individuals representing manufacturers associations. They were  
individuals who might have presented in connection with a clinical trial, for  
example, the hernia patch issue. There were people who may have been a third  
party or agents acting on behalf of Vitek or Novamed, but these were not people  
from National Health and Welfare. You could deem them to be promoters or  
stakeholders, I think is the word we used, for the product.116  
[106] In other words, they were the people interested in having the product come to market.  
The same people who would have conducted any tests necessary to show that it could be used  
safely and to the advantage of patients who were suffering.  
[107] Can the attitude of Pierre Blais, demonstrated by the broad statements he made, be  
explained or at least a context for understanding be identified? The controversy that surrounded  
his departure from Health and Welfare Canada was not the first time he had run afoul of its  
senior representatives. In April 1981, Pierre Blais was interviewed by a journalist working for  
the Ottawa Citizen in respect of the use of DEHP [“di(2-ethylhexyl) phthalate117] in blood  
transfusion products. He was quoted as saying that “those who give blood through  
plasmapheresis… Could face a long-term risk of kidney or liver injury” and that “the use of  
plastic containing DEHP is a senseless and unnecessary risk”118. Pierre Blais’ comments  
generated considerable consternation among senior officials at Health and Welfare Canada. In a  
memo dated May 4, 1981, addressed to the Director of the Medical Devices Bureau, the Director  
General of the Environmental Health Directorate, Dr. Emanuel Somers, expressed his concerns  
over Dr. Blaisconduct:  
Let me say that I regard Dr. Blais' performance to be alarmist, misleading, and, in  
the final analysis, irresponsible. To elaborate, Dr. Blais is employed as a research  
chemist to study and advise on the physical and chemical properties of  
biomaterials and polymers. He has not the expertise or capability to advise on the  
toxicology of chemical materials. That responsibility rests with the Bureau of  
Chemical Hazards, whose staff comprise a number of experienced toxicologists  
with the required knowledge and abilityOnce again, Dr. Blais is pontificating  
beyond his responsibility or expertise.119  
116 Ibid at p. 14  
117 Agency for Toxic Substances and Disease Registry, Division of Toxicology, Public Health Statement (September  
2002): “A manufactured chemical that is commonly added to plastics to make them flexible.”  
118 Transcript of Pierre Blais (May 13, 2019) at p. 528  
119Ibid at p. 52-528 and Exhibit 34, Tabs 11, 12 and 66  
Page: 36  
[108] There is a memo dated May 4, 1977. It is shown as being from “P. Blais, Materiaux De  
Las Medecine” to “B.N. Thivierge, Chef Division Des Affaires Reglementaires”.120 It is one of  
the four documents the authenticity of which was questioned by the Crown. The document along  
with the other three where the issue was raised was subjected to forensic analysis by experts  
employed by the Canada Border Service Agency in the Analytical and Forensic Services  
Division, Science and Engineering Directorate. I begin by observing that regardless of whether  
the document was “authentic”, which in the context of this case means that it was written on the  
date shown on its face as opposed to sometime later, it would be of little probative value. The  
document asked about the existence of files related to several stated subjects (“Sacs A Sang, Sac  
Pour Parenteraux, I.V., Specimens, Notification”) and asked specifically whether the recipient  
had a recollection of a file named “Silicone Injectable, Polytef and Proplaste”. The reference to  
Proplast in a memorandum asking whether there is a file that includes in its name the word  
Proplast does not help in understanding what was known or not known about material associated  
with that word.  
[109] The work done by the experts does not support a finding that the document was not  
prepared on the date shown, for the purpose stated. The document is not typed. It is  
“handprinted”. It has a handwritten signature above the printed name “P. Blais” and, in the upper  
righthand corner, above the printed letterhead, “MEMORANDUM NOTE DE SERVICE”, it  
has, in handwriting, words identified in evidence as “plastics site”. For the purpose of “Hand  
printing Comparisons” the document is included in the first of two groups of documents being  
examined. The conclusion respecting its authenticity, insofar as the hand printing is concerned,  
was stated as:  
Conclusion: this finding provides more support for the belief that the questioned  
hand printing entries in Group 1 were written during the latter period of the  
specimen hand printing from 1989 or later, rather than on the dates they are  
purported to be produced. However, this support, while greater for the belief that  
the writing is anachronistic than it being contemporary, is limited or weak.  
This comparison was hampered, and the conclusion severely limited, by 1) the  
small amount of specimen writing for the time period after 1989, and 2) the subtle  
and variable nature of the features upon which the assessment is based which  
creates significant uncertainty in the final conclusion.121  
[Emphasis added]  
[110] This document is dominated by the hand printing. Even so the experts go on to examine  
the signature found above the hand printed “P. Blais”. Under the heading “Signature  
Comparisons” this signature is dealt with in the second of two groups. The conclusion is as  
120 Exhibit 27 T. 2 and Exhibit 73 T. 3  
121 Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 37 of 84  
Page: 37  
Conclusion: This finding provides support for the belief that the questioned  
signatures on Items Q1 [the document presently being considered]…were written  
during the latter time period of the specimen signatures (2000 and after), rather  
than in the time period of the earlier specimen signatures (1966-1991). The level  
of support is considered to be strong.  
The comparison and the conclusion were limited somewhat by the relatively small  
amount of specimen material provided for the timeframe after 1991.122  
[Emphasis added]  
[111] To place the noted concern (being the small number of specimens available for the period  
after 1991) in context, the number of specimens relied on for the identified period are: two from  
1991, one from 2000, one from 2005 and three from 2018. To put it differently, “After 1991” but  
before 2018 there are only two specimens. The three from 2018 are all signatures by which  
Pierre Blais swore to the accuracy of three affidavits that bear his name. The expert  
acknowledged that this is an unusual circumstance. It is one which may lead a party to be more  
attentive of the act of signing.  
[112] The question being asked is a serious one. It is about the fundamental integrity of the  
individual involved. I am not prepared to find, on a balance of probabilities, that this document is  
anything other than what it appears to be.  
[113] I feel obliged to make a further observation. This is not the only one of the four  
documents being questioned which has little if any probative value in respect of the issues raised  
in this case. None of them do. From this, one has to wonder why the Crown felt compelled to  
continue with the issue of their authenticity. I asked about the purpose. The first time the  
question was asked, counsel indicated concern for what this might say about the integrity of  
Pierre Blais. When the issue arose again the Court was advised that there is a separate  
application brought by the Plaintiff by which her counsel seeks to demonstrate that the Crown  
destroyed documents presumably knowing them to be relevant to this case. Counsel for the  
Crown expressed the view that any decision made in these reasons respecting this issue could  
impact that further application. To the extent that the rationale for the inquiry into the  
authenticity of these documents is the impact these reasons may have on a further application, it  
is collateral to the matters of concern in this trial. If it is the only true purpose, it is improper. The  
issue of the destruction of documents is not before the Court. To my mind, any findings made  
here should not be taken as determinative of issues to be raised after what would be a more  
complete evidentiary investigation specifically directed to those questions.  
[114] There was some confusion as to what exactly Pierre Blais did upon his return from the  
Gordon Conference. In an affidavit he swore on January 16, 2000 he deposed that “after my  
122 Ibid at p. 38 of 84  
Page: 38  
return to Canada I wrote a proposal recommending the prohibition against materials like  
Proplast/Vitek.” In this affidavit Pierre Blais goes on to say that he took his recommendation that  
Proplast be prohibited to his superior, Dr. Ron W. Campbell, that “to the best of [his]  
information knowledge and belief” Dr. Ron W. Campbell passed the recommendation on to the  
Director of the Medical Devices Bureau, Dr. Ajit K. DasGupta, that on the same basis he  
understands that Dr. Ajit K. DasGupta agreed with the recommendation and passed it on to Dr.  
Emmanuel Somers, who according to the information, knowledge and belief of Pierre Blais  
rejected the proposal. There is no document that would support this recollection. The Rules of  
Civil Procedure, at the time this affidavit was sworn, as they do now, required that when a fact is  
attested to on “information and belief” the source of that asserted knowledge is to be  
“specified”123 It was not. The affidavit goes on:  
The reasons for my proposal were included in the written material, which was part  
of a Bureau proposal for amending the Medical Devices Regulations.  
[115] There is a document directed to amending the regulations. It is entitled “A Need for  
Enhanced Regulatory Control of Invasive Medical Devices.”124 It first appears in company with  
a covering memo dated May 28, 1981.125 It does not mention the prohibition of Proplast  
products. In cross-examination counsel tried to clarify the uncertainty. Counsel suggested that  
the proposal for prohibition must be in some other document and Pierre Blais answered:  
Q. So that, this, I take it, sir, is a different, because of the timing, a different  
proposal or recommendation that you wroteThat's a different one than the one  
we looked at that's dated, that's at Exhibit 27, tab 7, from 1981. This is a different  
one. Is that right?  
A. It -- what you're referring to is probably the first ancestor to the series of  
memoranda of which you have one, what we have called the 1981 memorandum.  
The -- there was -- we discussed a few minutes ago my preparation of documents  
for Dr. Campbell to brief his superior, and it did -- that was the very first of the  
documents which ultimately led to many others, including the last one on  
ophthalmic products. It was the first ancestor.126  
[116] There is no series of documents as referred to. The one that was produced does refer back  
to the Gordon Conference albeit five years later, as of May 28, 1981:  
During the late seventies, Dr. Homsy and his associates made numerous  
conference presentations and published a series of papers presenting Proplast  
applications and the outcome of clinical studies. All conveyed information which  
seemed contrary to basic medical and scientific principles. The findings also had  
promotional overtones and were met with scepticism [sic]. At a 1977 conference  
123 Rules of Civil Procedure R.R.O. 1990, Reg. 194 at R. 39.01(4) and (5)  
124 Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4  
125 Exhibit 27 v. 1 T. 7 and 73 T. 4  
126 Transcript of Pierre Blais (May 10, 2019) at p. 479  
Page: 39  
of assembled biomedical leaders, pathologists and regulatory affairs specialists,  
Dr. Homsy’s presentation was savaged by members of the audience.127  
[117] The document does not propose the prohibition of Proplast or similar products. Rather it  
proposes the following:  
In light of the present information, all Vitek, Proplast and Proplast-like implants  
should be placed in a special category subject to close supervision by hospital or  
professional ethics committees. If adverse events continue to be reported, the  
product should be sequestered by the field operations directorate until the  
regulatory status is clarified. A similar caveat should apply to any medical  
implant based on graphite, glass or other high-performance fibers with or without  
a consolidating matrix substance.128  
[118] Pierre Blais said, in his evidence, that this document was prepared as part of submissions  
to be made to Treasury Board. This is confirmed by the covering of memo:  
Rationale for regulatory amendments  
Following our discussions with Dr. DasGupta, I have updated the Divisions  
rationale for regulatory amendments for our next Project Review.  
As requested, I have added a discussion on countermeasures and regulatory  
options. Expanded briefings can be drafted for TB [Treasury Board] submissions.  
[119] The document appears more than once. Not only is it presented as of May 28, 1981, it  
and the memorandum which encloses it, reappear. On the second version the typed date “May 28  
1981” is struck out and replaced in handwriting by the date “Feb. 18, 82.” As explained by Pierre  
Blais the document was used twice to assist in the preparation of the annual submission made to  
the Treasury Board on behalf of the Bureau.129 The second version has a further handwritten note  
asking “Linda” to have the file printed with large type “for Dr. DasGupta’s TB sub”.130  
[120] These submissions produced a positive result. They led to the amendments to the Medical  
Devices Regulations that added to the Schedule to Part V any “new device” designed to be  
implanted into the tissues or body cavities of a person for 30 days or more. As already noted, the  
amendment was made on October 8, 1982 and became effective on April 1, 1983. Following a  
review of the document I asked and Pierre Blais responded:  
127 Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 13. There was some confusion as to  
whether the Gordon Conference took place in 1976 or 1977. In the end, despite what was said here, it was  
determined to have been held in 1976.  
128 Ibid at p. 14  
129 Transcript of Pierre Blais (May 2, 2019) at p. 25-26  
130 Exhibit 27 v. 1 T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4  
Page: 40  
THE COURT: All right. Now, looking not backwards from that but looking  
forwards to where this went ultimately, ultimately, if I understand this correctly,  
all of this concern leads in the end to the amendment in the regulation Part V in  
1983, in which now we see these kinds of implants, implants that are going to be  
input and last for more than 30 [days], becomes part of Part V.  
A. Exactly.131  
[121] As it turned out, these three documents, the two versions of the covering memorandum  
and the paper, “A Need for Enhanced Regulatory Control of Invasive Medical Devices” are the  
second set of documents where the authenticity is challenged. The primary concern with the  
paper arises not from handwriting or hand printing but from the type face used. In the early  
1980’s modern office machines were beginning to appear. However, Health and Welfare  
Canada, as most offices of the day, still used typewriters. This was determined by a review of  
documents produced at the time. Typewriters are distinguishable from more modern machinery  
as impact printers: the paper is struck by a letter either on an arm or ball. Typewriters utilized  
“mono spaced” print. The letters, regardless of their form, take up the same width. The letter “m”  
takes up the same space as the letter “i”.132 More modern office machines use “proportional  
spaced” print. The width of the letters varies.133 The printing on the documents was  
proportionally spaced. The type face (font) was identified as Helvetica which had existed since  
1961 and was based on designs that go back to 1957.134 This design was not seen on any known  
documents with typewritten entries at Health and Welfare Canada.135 Glyphs (described as  
letter/character design) for example  
were observed to be different from those of  
Helvetica and other similar versions. The experts from the Canada Border Service Agency  
A Helvetica style of typeface was not seen on any known documents with  
typewritten entries at Health and Welfare Canada.136  
[122] They went a step further; they searched typewriter databases to see whether the typescript  
on the documents in question could be found in any proportional spacing typewriter. Such  
spacing was not common in typewriters at the time. No typeface in any of the identified  
classification systems were observed that corresponded to the typed entries being examined. The  
glyphs “TM” and “R” were not commonly available in any typewriters from the time.137 The experts  
found that:  
131 Transcript of Pierre Blais (May 10, 2019) at p. 483-484  
132 Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 58 of 84  
133 Ibid at p. 59 of 84  
134 Ibid at p. 18 of 84  
135 Ibid at p. 19 of 84  
136 Ibid p. 19 of 84  
137 Ibid at p. 19 of 84  
Page: 41  
Accordingly, no features were observed to indicate that the typed entries depicted  
on documents Q2 (1-22) were produced on any typewriter, at Health and Welfare  
Canada or available elsewhere, in the time period in question.138  
[123] The forensic experts also examined the handwriting that appeared on the covering  
memorandum. This includes the note asking “Linda” to print the document in larger script, the  
handprinted date and the signature “P. Blais”. In each case the determination is the same. The  
script tends to be consistent with the specimens of the date shown on the document: it is  
“contemporary” rather than “anachronistic”. Thus, these results are different than those  
associated with the typed script. However, as a result of the lack of later specimens from the later  
time frame the experts do not foreclose the possibility that the hand writing was nonetheless  
from a later date than shown on the face of the document.139  
[124] Obviously, this leaves the situation confused. The handwritten and printed script tends to  
the documents being contemporary and the typed script to a later anachronistic date. The experts  
acknowledged that while at the contemporary time the typed script was unlikely to have been  
produced by a typewriter, there were “commercial printers” that were capable of producing the  
script used. Work they had done to establish the equipment utilized by Health and Welfare  
Canada, at the time contemporaneous to the dates shown on the face of the covering memoranda,  
provided no indication that there was machinery available from contractors involved, who might  
have had access to printers with the capacity to produce the script used.  
[125] Although not a party to the action, Pierre Blais was examined for discovery. In the course  
of this questioning Pierre Blais alluded to the possibility of the printing of these documents  
having been done out of the normal context:  
In 1982 the printing that you see in your hand is an alien printing. It comes from a  
contractor or a machine that was not familiar to me. It was a wizardry of a  
computer specialist who essentially reprocessed obsolete medium in order to  
extract the original text.  
[126] During that examination Pierre Blais referred to a company that he said had a contract  
with what was then Health and Welfare Canada “for our word processing system”:  
They produced software…and they produced customize systems for correlative  
data at National Health and Welfare, and probably other departments as well.  
They also did some kind of service on printers. And, they periodically, I think,  
loaned us printers, including kinds that I’ve never seen before.140  
138 Ibid at p. 19 of 84  
139 Ibid at pp. 35-36, 37 and 38 of 84  
140 Transcript of the Examination for Discovery of Pierre Blais (February 5, 2019) at pp. 210-212  
Page: 42  
[127] Counsel for the Crown was quick to point out that, in the absence of the ability to cross-  
examine Pierre Blais on these matters this evidence was, at best, hearsay.141 However, the  
question was not whether it should be accepted for its truth but whether it stood as a suggestion  
the experts were aware of as they undertook their work. The forensic expert providing this  
evidence was Tobin A. Tanaka. He had read some transcripts before coming to his conclusions.  
It was his recollection that he had read of the individuals named in the transcript as associated  
with the suggestion that an outside printer could have been involved. Neither he nor the other  
expert, R. Brent Ostrum, had conducted any further investigation into this possibility. It was  
beyond their mandate. Their concern was as to the physical properties of the documents not their  
source, context or content.  
[128] If I were required to do so, I would on a balance of probabilities, conclude that these  
documents are authentic, that is they are as they appear. The main document “A Need for  
Enhanced Regulatory Control of Invasive Medical Devices” is comprehensive dealing with far  
more than just Proplast products. Pierre Blais proposed that there were many more versions but  
there are only two that appear in the record (1981 and 1982). The two are consistent with the  
stated purpose of assisting in demonstrating to Treasury Board that more was required to  
properly regulate medical devices. This was apparent from both the overall subject matter and  
the timing leading, as it does, to the amendments made on October 8, 1982 and made effective as  
of April 1, 1983.  
[129] As it is, the value of these documents as providing information supporting a position that  
the accepted knowledge about Proplast was such that it should have led inexorably to a  
conclusion that products using Proplast should never have been allowed into the market is  
minimal if it exists at all. Why is this? It is because Pierre Blais, for all that he is relied on as the  
beacon of this idea, acknowledged that amendments to the Medical Devices Regulations that  
added implants that were to stay in the body for 30 days to those to be treated under Part V of  
those Regulations was a sufficient response to the issues as he saw them. There is no document  
demonstrating that a prohibition was ever asked for.142 There was no need for an absolute  
prohibition whether or not one was ever proposed:  
THE COURT: And I thought it was -- and you didn't say this before. I just sort  
of remembered it when I was trying to work out in my own mind something that  
you said. Remember that you said: When we ask for things, I dream; I ask for  
everything that I could possibly want, and sometimes all I get is what I need. Do  
you remember that?  
A. Yes.  
THE COURT: And I thought that maybe this fits that understanding of how this  
works: You asked for a prohibition, didn't get it but got what you needed because  
you got to examine the safety and efficacy of it?  
141 One of the people referred to “Barbara Goldhamer” was identified by Pierre Blais in his viva voce evidence albeit  
for a different purpose (Transcript of Pierre Blais (May 1, 2019) at pp. 100-101)  
142 Transcript of Pierre Blais (May 10, 2019) at p. 484  
Page: 43  
A. Yes. It was time when we accepted reality.143  
[130] In fact, it was what he had proposed in the document entitled “A Need for Enhanced  
Regulatory Control of Invasive Medical Devices”:  
Regulation Amendments are Inevitable  
The present medical devices regulations enable inclusion of supplemental device  
categories to the list of ‘high risk’ products. Accordingly, case-by-case addition of  
specific product categories that embody risks at par or greater than those of the  
present classes subject to the provisions of Part V. A timetable setting the date  
when each of the new categories become subject to the new requirements would  
then be proposed for comment by industry and consumer representatives.  
Alternatively, a new set of classification criteria for devices subject to Part V  
requirements could be created. It is noteworthy that all, except one, device classes  
presently comprised under terms of Part V are implants. …  
[131] This was followed by a proposal for the classes of devices that could be added to Part V.  
The first of which was:  
Missing Major Classes  
All of the presently-listed Part V device categories and most classical implants of  
other types would be captured under the term “implant”. Thus, a device intended  
to be inserted in tissue or a body cavity or expected to be in intimate body contact  
for an indeterminate period would become subject to the provisions of Part V. The  
issue of contact time is moot. A large body of research and retrospective clinical  
studies have demonstrated that direct contact with a faulty device for about a  
month is sufficient to impart severe damage to user exposed to an injurious device  
that does not have an essential physiologic or mechanical function. The presently  
cited “30 day” watershed exposure would thus be retained.144  
[132] This offered the public a level of protection:  
THE COURT: Okay, just a minute. So dreaming or dreams includes the  
understanding that there would always be a limit on what the regulations would  
allow, which I take to mean that there was an acknowledgment that there were  
other considerations that regulators would bring to bear on the question which  
would probably mean you would not get exactly what you wanted in terms of  
regulatory power.  
A. Yes, absolutely correct.  
143 Transcript of Pierre Blais (May 13, 2019) at p. 633  
144 Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 2  
Page: 44  
THE COURT: All right. And then what you needed was for what you said was  
minimal protection, therefore it was something less than the dream, but something  
that would provide you with some level of regulatory authority to provide for  
some level of protection to the public.  
A. Yes.145  
[133] It was a compromise:  
THE COURT: Okay, from which I deduced that -- and I'm asking now -- that  
what we have here, as you have now described it, is an appearance of a concern,  
the evolution of that concern into fear, and a process by which the various  
competing points of view worked, ultimately winding up at what you've called a  
compromise, which was, in effect, the 1983 inclusion of the 30-day rule, which  
would have taken in Proplast and any consideration of it?  
A. Exactly.146  
[134] Pierre Blais acknowledged this was typical of how amendments to regulations came to  
be. He was asked:  
THE COURT: So I want to say again and make sure I have this established with  
you, that this is something you understood at the time, that this was a typical  
evolution of a regulatory change.  
A. Exactly147  
[135] This is not evidence that demonstrates a dedication to the prohibition of Proplast products  
but rather the expression of concern, the acceptance of that concern and, in time, the arrival at  
what was accepted as an appropriate regulatory response.  
[136] The document (“A Need for Enhanced Regulatory Control of Invasive Medical Devices”)  
was put to Janice Hopkins. She had been employed at Health and Welfare Canada from 1969 to  
1979. She left and went to the Department of Fisheries and Oceans. She returned during 1980 as  
the Director, Atlantic Region (Halifax). From 1982 to 1985 she was the Director of Management  
Processes working in the Assistant Deputy Minister’s office. She was responsible for, among  
other things, how resources were allocated. She and her staff provided the rationale to be put to  
Treasury Board for the requests being made. Janice Hopkins does not recall the document (“A  
Need for Enhanced Regulatory Control of Invasive Medical Devices”). It needs to be  
remembered that she only returned to Ottawa during 1982. More importantly, the evidence  
provided by Janice Hopkins confirms the thrust of that paper to the effect that more resources  
were required to properly regulate medical devices and their entry into the market in Canada. She  
145 Transcript of Pierre Blais (May 1, 2019) at p. 20  
146 Transcript of Pierre Blais (May 10, 2019) at p. 486  
147 Transcript of Pierre Blais (May 14, 2019) pp. 632-633  
Page: 45  
identified the minutes of a meeting of the Cabinet Committee on Social Development held on  
March 4, 1981, prior to her moving to Ottawa in 1982.148 Apart from the members of Cabinet,  
staff from several of the interested government departments were present. This included four  
people from Health and Welfare Canada including “Mr. E. Somers” who Pierre Blais said turned  
back his recommendation that Proplast be prohibited.  
[137] The Committee had for consideration a Memorandum dated February 3, 1981 and  
Discussion Paper of the same date, submitted by the Minister of National Health and Welfare,  
recommending increased resources for the Medical Devices Program to permit it to more  
adequately carry out its responsibilities under the Food and Drugs Act.149 The Minister of  
National Health and Welfare opened the discussion. She began by…  
… answering a question posed earlier by the Ministry of State for Social  
Development regarding other options for dealing with the problem of regulating  
the safety and efficacy of imported medical devices. She explained that her  
department already uses information from United States regulatory agencies, the  
Canadian Standards Council and other reliable agencies but that this alone is  
inadequate for improving controls to the necessary level. The proposed approach  
is sufficient to deal with the most dangerous devices and usage abuses, but given  
the very large number of devices imported from over 30 countries, the rapid rate  
of technological change and the sophistication of the technology, it will always be  
impossible to check every device type. The provinces help to some degree by  
certifying use of certain devices within their territory, but sharing of the work of  
testing devices and setting standards could result in fragmented standards and a  
fragmented market. She asked to be excused from the study of options requested  
by the ministry, since she is satisfied that there are no practical options and that  
the only means of reducing expenditures would be to impose a user fee. This  
could increase healthcare costs.150  
[138] The Discussion Paper under the heading “RECAPITULATION” summarized the  
recommendation being made:  
The main points raised in the foregoing are:  
Medical devices are essential for modern healthcare but many sold in Canada are  
hazardous or ineffective and cause avoidable health or injury.  
The Department of National Health and Welfare is responsible under the Food  
and Drugs Act for ensuring that manufacturers sell only safe and effective  
148 Exhibit 55 at T. 3  
149 Ibid at T. 3, p. 15 and respectively at T. 1 and T.2  
150 Ibid at T. 3, p. 15-16  
Page: 46  
The Department is unable to fulfil this responsibility adequately with present  
Regulatory control of devices in Canada must cope with the unusual situation  
arising from the lack of domestic manufacturing the high dependence and demand  
for technology by the healthcare delivery system.  
A collaborative strategy involving the government, manufacturers and users,  
tailored for the Canadian situation, is proposed. This requires 20 PY [person  
years] in 1981-82 and an additional 14 PY in the following year for a total of 34  
PY to:  
Ensure reasonable probability of safety and effectiveness of the  
highest priority inventions before open marketing;  
develop essential performance and safety standards and testing  
capability; and  
take corrective and preventive actions in response to report of the  
most severe device failures.151  
[139] The proposal for a collaborative strategy involving the government, manufacturers and  
users was accepted. The Record of Cabinet Decision, dated December 8, 1981, noted:  
8. Medical Devices Program  
(1) the proposal be approved but the question of additional person years be  
considered by the Treasury Board;  
(2) the Minister of National Health and Welfare be requested to develop an  
overall policy on the question of allocation of costs in relation to testing the safety  
of drugs and devices and to report back to the Committee within a year.152  
[140] The need for additional person years was recognized, the costs acknowledged but  
approved. The approval was explained in a letter to the Deputy Minister dated February 24,  
Dear Mr. Fry:  
Your minister’s submission seeking resources for an expanded program testing  
and evaluation of medical devices was re-considered by the Treasury Board on  
February 11, 1982. In addition to the approvals given by the Treasury Board at its  
151 Ibid at T. 2 (Discussion Paper) at pp. 21 and 22  
152 Ibid at T. 4 (Record of Cabinet Decision) at p. 5  
Page: 47  
meeting of July 23, 1981, as contained in my letter of July 30, 1981, Ministers  
approved the following:  
inclusion of an item in Supplementary Estimates 1982-83 of 20 person-  
years and associated salaries of $503,000 for the medical devices program;  
an increase in your departments reference levels of 34 person-years and  
associated salaries of $855,000 in 1983-84 and subsequent years.  
Ministers requested the department to report to the Treasury Board no later than  
January 1984 on the appropriate level of service for the medical devices program,  
based on information available at the time.  
Yours sincerely,153  
[141] This approach and these considerations demonstrate a recognition of the concerns  
associated with the regulation of medical devices. These actions were a substantial effort to  
adjust the approach and provide appropriate resources not just with respect to Proplast products  
but the broader concern for medical devices at large. This is consistent with the document “A  
Need for Enhanced Regulatory Control of Invasive Medical Devices” the content of which went  
beyond concern for a single product type and proposed solutions within the regulatory scheme as  
opposed to an absolute prohibition of Proplast products. With the October 8, 1982 amendments  
in place, the regulatory approach can be seen as collaborative. It relies on:  
the manufacturers and distributors to undertake the necessary testing,  
the government to consider whether, based on the information provided, a  
reasonable probability of safety and efficacy has been demonstrated for the  
highest priority inventions (i.e. those to which Part V apply), and  
users (doctors, hospitals and patients) to report on difficulties that may appear.  
[142] The decision to adopt a collaborative approach was an important one, made at a crucial  
moment in the evolution of the policy governing the treatment of medical devices. It is a decision  
that informed, modified and explains what happened thereafter in connection with the regulation  
and regulatory activity that affected this area of concern.  
[143] Those efforts did not stop with those amendments becoming effective as of April 1, 1983.  
The record of this trial includes a document dated February 1985, entitled:” Medical Devices  
Program, Health Protection Branch, Department of Health and Welfare, Workload Submission”.  
It is a proposal to obtain approval to include in the 1985-1986 Supplementary Estimates  
153 Ibid at T. 6  
Page: 48  
increased funding to allow delivery of the approved minimum level of service for the Medical  
Devices Program.154  
[144] This is not to say that over time, from time to time, government demands did not require  
adjustment to the resources made available. A letter dated September 26, 1985, from the Minister  
of Health and Welfare Canada to the President of the Treasury Board is a case in point. It does  
not deal specifically with medical devices. It reads in part:  
The updated Multi-Year Operational Plan for my Department is being forwarded  
to the Treasury Board Secretariat. As requested this plan incorporates our detailed  
proposals for reducing our person-year (PY) requirements over the next five-year.  
To achieve the targets proposed to us by the Treasury Board Secretariat.  
As will be seen in the detailed plan, we have been able to identify a variety of  
person-year reductions which will enable us to meet our targets. Indeed, we have  
identified possibilities for PY reductions which are considerably in excess of our  
[145] The same letter maintains the concern of the ability of Health and Welfare Canada to  
have the resources necessary to undertake its responsibilities:  
The MYOP also identifies those areas where we require additional resources to  
meet unavoidable workload increases, to carry out new governmental decisions,  
and to cover increases in the costs of maintaining a non-discretionary level of  
However, I do have to put on the record the fact that I am able to offer reductions  
of this magnitude only on the understanding that new resources would be made  
available to enable me and my Department to meet essential requirements for  
which there is no provision in current reference levels, whether these arise from  
new government decisions or from unavoidable workload increases. Without this  
understanding, clearly I could not make all these cut-backs from departmental  
person-year resources, because it would become essential for me to divert  
resources to other requirements.155  
[146] This followed a one-person year cut imposed on the Environmental Health Directorate of  
which the Bureau of Medical Devices was part, effective April 1, 1984. Of this a 0.33 PY cut  
was allocated to the Bureau. At the same time a similar cut of 0.33 PY “temporarily” for the last  
154 Ibid at T. 9  
155 Ibid at T. 13  
Page: 49  
few months of 1983-1984 was extended indefinitely.156 To my mind, these are small changes  
made in response to policy adjustments that mark the constant evolution of government  
priorities. They do not signify any change in the commitment to, or inadequate support for, the  
regulation of medical devices.  
[147] Through the early 1980’s the regulatory scheme was amended to meet the challenge  
posed by the increased interest in, development of and demand for medical devices. The  
changes, while not what Pierre Blais says he “dreamed of” as the response to products that  
included Proplast, were sufficient to allow for protection of the public. What was the general  
understanding of the utility of Proplast and the medical devices in which it was included? It was  
not universal acceptance that it was dangerous or that any harm associated with it outweighed  
any benefit. In 1983 a book was published157: “Biomaterials in Reconstructive Surgery.” The  
book was edited by Dr. Leonard R. Rubin. Some of his credentials are listed on fronting page of  
the book: for example, “Diplomate, American Board of Plastic Surgery; Clinical Professor,  
Plastic Surgery, State University of New York, Stony Brook and Director, Plastic [and]  
Maxillofacial Surgery and Burn Center, Nassau County Medical Center, East Meadow.158 The  
book was described by Pierre Blais as a “teaching textbook on plastic surgery.159  
[148] Pierre Blais explained to the Court that he had worked with Leonard R. Rubin at the  
facilities of the State University of New York in relation to a Proplast chin implant.160 He said  
that work demonstrated that part of the Proplast implants had disintegrated and scattered over  
about a half-inch of tissue. The implant was surrounded by a layer of pus.161 This information  
was conveyed to his superiors at Health and Welfare Canada “between ‘79 and ’80;”162 which is  
to say years before the book was published and before the amendment to the Medical Devices  
Regulations which added these implants to those devices being treated by Part V.  
[149] Leonard Rubin is shown as the author of Chapter 30 of the book, the chapter in which the  
work of Pierre Blais is reviewed.163 It refers to the observation of two patients with mandibular  
implants: one placed for 32 years the other for 18 years. These were the tissues evaluated by  
156 Ibid at T. 9, p. 6  
157 Pierre Blais first testified that the book was published in 1981 (Transcript of Pierre Blais (May 1, 2019) at p. 98)  
but the book itself bears the date 1983 (Exhibit 34 v. 1 T. 17 and T. 19) and Pierre Blias subsequently agreed it was  
published in 1983 (Transcript of Pierre Blais (May 3, 2019) at p. 404)  
158 The complete list found on the fronting page includes: “Attending Plastic Surgeon, Nassau Hospital, Mineola and  
Mercy Hospital, Rockville Centre; Honorary Plastic Surgeon, North Shore University Hospital, Manhasset, New  
York [and] 1978 Chairman of Gordon Research Conference in Biomaterials.”  
159 Transcript of Pierre Blais (May 1, 2019) at p. 98  
160 Transcript of Pierre Blais (May 3, 2019) at pp. 399-400  
161 Ibid at p. 401  
162 Ibid at p. 402  
163 Exhibit 34 v. II T. 98  
Page: 50  
Pierre Blais. The implants used polyethylene, not Proplast. Pierre Blais acknowledged the work  
he did, that is reported in the book, does not consider any Proplast product.164  
[150] To the contrary, insofar as Proplast is concerned, the book suggests something quite  
[151] Chapter 31 of the book is entitled “Clinical uses of Proplast: expectations and results”  
Pierre Blais said he reviewed the chapter and prepared a critique. He “may have” a copy it but it  
was not produced.165 The results of the studies reported in this chapter include:  
The extensive amount of experimental animal studies that preceded its use in  
humans included the usual small laboratory animals as well as canine and primate  
implantations, which later were followed in a few cases much longer than the  
usual [illegible] period under the direction of the original experimenters who  
continued their observations to their clinical usages. The continued clinical  
observation of the implants has allowed interim biopsies, which were quite  
desirable. A collation of a total series reported to the manufacturer’s lead to a  
review of a series of 900 clinical implantations with the rejection rate of less than  
Our histological review of these implants and their capsules have shown that all  
the implants are surrounded by pore spaces invaded by multinucleated giant cells.  
However, we have noted that the population of the giant cells seemed to diminish  
with prolonged fibrous tissue in growth though this is based on segmental  
biopsies of clinical patients rather than total removal of the implant and its  
surrounding tissue reaction for study. Nonetheless, in a few patients because of  
gross irregularity or too large a prosthesis, large sections were removed and  
studied after several years of insertion and they confirmed the experimental  
findings in those primates studied for a period from 3 to 5 years-firm in growth  
with adequate fixation.167  
Surface fragmentation  
There is surface fragmentation, and when the material is examined under a  
microscope (Fig. 31-4), one would expect this of a fiber-felt multi-open pored  
implant. Bits of surface fragmentation have been found as inclusions in  
multinuclear giant cells (Fig. 31-5) nonetheless, the implants have clinically  
164 Transcript of Pierre Blais (May 3, 2019) at pp. 409-410  
165 Exhibit 34 v. I T. 19  
166 Transcript of Pierre Blais (May 13, 2019) at p. 585  
167 Exhibit 34 v. I T 19 at pp. 494-495  
Page: 51  
maintained the initial contour with no clinically palpable detection of the minimal  
fragmentation or migration of material. Darkening of the skin, in superficial  
locations, such as the nose, the periorbital region, or any area with scar covering  
or thin overlying skin with little subcutaneous tissue, by black phagocytized  
material has appeared in the dermis can be progressive. This is believed to be a  
significant problem in and around the thin tissues and after superficial removal  
reoccurrence has been noted, requiring not only the substitution of the Proplast I  
with other materials but also, on two occasions, resection of the surface covering.  
The migration of material has [illegible] sufficiently serious around the nose and  
the periorbital region and one chin to necessitate total removal of implant and its  
surrounding fibrous tissue and its initial replacement with either a dermis or  
superficial that flap followed at a later date by implementation of other  
The clinical experience over the past 10 years has been reviewed in an ongoing  
accomplice and report on more than 900 human implantations with Proplast I that  
were carried out internationally by surgeons of various backgrounds using varying  
techniques and with varied methods of implant and recipient site preparation. The  
use of the implant material was preceded by a 5-year intensive experimental study  
of the biocompatibility of Proplast varying anatomic areas and many different  
animals, from mice to primates, as well as continuing and repeated studies  
biocompatibility in with tissue cultures. In 1973, “The Clinical Use of a New  
Porous Implant: Proplast”,” a review of a five-year serial studies of this material  
in baboons, was presented to the Association of Plastic Surgeons. In 1975 a 4-  
year ongoing clinical study of human Proplast implantations included alveolar and  
maxillary augmentation, coating of self-stabilizing condylar prostheses,  
mandibular augmentation, soft tissue replacement and reconstruction of costal,  
sternal, facial and cranial bone deformities. A survey conducted by Kent et al.,  
presented at the International Biomaterials Congress in April 1980, reviewed 700  
patients and demonstrated “immediate and delayed” success rates well in excess  
of 90%. The literature of the past few years contains reports by experienced  
plastic surgeons, maxillofacial surgeons, otolaryngological surgeons, oral  
surgeons, and even ophthalmological surgeons, as to the uses and proposed use of  
Proplast I. Although all the ophthalmological clinical trials were experimental,  
Proplast was well tolerated as implants in the cornea and skilled era and obviously  
a good deal has yet to be studied, including the rate of post-tissue in growth in the  
long-term acceptance of the alloplast….169  
168 Ibid at pp. 498-501  
169 Ibid at p. 501  
Page: 52  
Proplast has fulfilled to a large degree the criteria that were planned in its original  
development; it has a minimal reactivity and is thermostable, and the surface  
porosity allows penetration by the adjacent fibroblasts and a certain amount of  
tissue fixation. Although relatively easy to shape, there are problems involved  
with irregularities, possible feathering of edges, which may, at a later date, flare.  
But its low elastic modulus is sufficient to allow gentle massage and external  
compression though direct incision and revision of the implant has been carried  
out. Except for the one case mentioned, our incidents of infection has been  
extremely low. We have had implants that have developed seromas around the  
larger sections, possibly because of rib-cage motion during breathing but  
eventually tissue fixation has been excellent. We have not seen fixation correlate  
with deep penetration, nor have we seen even the long-term cases show a good  
bony scaffold. There has been a tendency to fragmentation of the surface with  
encapsulation of particles by macrophages, which seem to have migrated to the  
dermis. To date this has only been apparent in the superficial dictations below thin  
skin flaps or adjacent thin scars. It may be that the light-colored Proplast II may  
satisfactorily eliminate this problem, but a further long-term follow-up study is  
[152] This chapter and the studies to which it refers do not confirm that by the early 1980s  
there was an understood and comprehensive conclusion that any harm caused by the  
implantation of Proplast products would inexorably outweigh the benefits that could be achieved.  
[153] The chapter in which this appears was written by Charles Homsy, the developer of  
Proplast. Given his expressed concerns, Pierre Blais was asked why the editors of the book (he  
was one of them) decided the chapter was worthy of inclusion. The reason? Maybe Charles  
Homsy was right:  
…collectively in consensus, we decided to err using the logic that was presented  
by His Honour. We reasoned: What if Charles Homsy were right; therefore give  
him a springboard or maybe a point to express his views and let the rest take place  
as it should. We left it to the reader to decide for themselves. That was the  
THE COURT: But it raises the prospect that it was still believed by the group as a  
whole, maybe not all the individual members, that it was still possible that Homsy  
was right.  
170 Ibid at pp. 507-508  
Page: 53  
A. Yes.171  
[154] According to Pierre Blais this happened well before the book was published. The  
decision was taken in 1979, still after the furor Pierre Blais says took place, at the Gordon  
conference, in opposition to Charles Homsy.  
[155] Dr. Doran Ryan is an American maxillofacial surgeon. He is a teacher and frequent  
speaker on the subject. Doran Ryan provided evidence as to the history of the effort to deal with  
problems associated with the temporomandibular joint. 1982 was a significant year. There were  
advances in the applicable radiology. It had not been possible to inject dye into an area as small  
as the temporomandibular joint. This became feasible in 1982 making it easier to identify the  
kind of problems involved. Prior to this advance it was difficult to identify the problem when  
patients complained of pain or discomfort. In some cases, it was thought to be purely  
psychological. In others, more conservative treatment was used: muscle relaxants, anti-  
inflammatory drugs, painkillers and other areas of expertise such as neurology. Even with the  
improved imaging these “modalities” were still used. Some surgical treatments were undertaken.  
Doran Ryan referred to “Dr. Brown” who was taking out the meniscus with a high degree of  
success. He had about a 20% failure rate. Beginning in or around 1963, surgeries were  
undertaken, where part of the bone was removed and replaced with a block of solid silicone  
(described as “gap arthroplasty with implant”). In 1980, efforts were made to reposition the disc.  
When it became apparent that repositioning the disc, after displacement, was not always  
possible, the disc was removed and solid silicone sheeting used as a replacement. This was  
expected to last for years. However, silicone did not have sufficient strength and tended to tear.  
A different solution was needed.  
[156] As reported by Doran Ryan, the first published results regarding Vitek Proplast Block as  
an interpositional implant appeared in 1982, when for example Kiersch reported a 93% success  
rate over nine years for 250 implants:172  
No, no. Vitek did the studies. They have files, a mechanical engineer that did  
those studies, and that's what they had. And they also had -- by the time I used  
that product in [1983],173 they already had nine years of experience implanted in  
the patients as produced by Kiersch in his study in [1984] that he presented. So,  
I'm looking at nine years of history of the product implanted in patients, and also  
looked at their bench studies they did on wear of the product174  
171 Ibid at p. 614.  
172 Exhibit 51 T. 10 (Ryan, Doran E: Alloplastic Implants in the Temporomandibular Joint, Oral and Maxillofacial  
Surgery Clinics of North America-Vol. 1, No. 2, December 1989) at p. 428  
173 The transcript does not say 1983. It says 1993. The evidence of Doran Ryan was clear. He placed Vitek Proplast  
implants from 1983 to 1985. By 1987 he had “explanted” all of these implants. It is my assumption that the  
transcript contains a typographical error. In the transcript the Kiersch study is referred to as reported in 1994. The  
citation for that study is: “Kiersch TA. The use of Proplast-Teflon implants for meniscectomy and disc repair in the  
temporomandibular joint [Abstract]. Presented at the AAOMS Clinical Congress on Reconstruction with  
Biomaterials, San Diego, 1984”. Again, I believe the reference to 1994 is a typographical error.  
174 Transcript of Doran Ryan (June 4, 2019) at pp. 10-11  
Page: 54